TITLE 21--FOOD AND DRUGS § 868.2340 - Compensated thorpe tube flowmeter.

CHAPTER I--FOOD AND DRUG ADMINISTRATION § 868.2350 - Gas calibration flowmeter.

DEPARTMENT OF HEALTH AND HUMAN SERVICES § 868.2375 - Breathing frequency monitor.
SUBCHAPTER H--MEDICAL DEVICES § 868.2377 - Apnea monitor.
PART 868 ANESTHESIOLOGY DEVICES § 868.2380 - Nitric oxide analyzer.
Subpart A--General Provisions § 868.2385 - Nitrogen dioxide analyzer.
§ 868.1 - Scope. § 868.2450 - Lung water monitor.
§ 868.3 - Effective dates of requirement for § 868.2480 - Cutaneous carbon dioxide (PcCO2)
premarket approval. monitor.
§ 868.9 - Limitations of exemptions from section § 868.2500 - Cutaneous oxygen (PcO2) monitor.
510(k) of the Federal Food, Drug, and Cosmetic Act § 868.2550 - Pneumotachometer.
(the act). § 868.2600 - Airway pressure monitor.
Subpart B--Diagnostic Devices § 868.2610 - Gas pressure gauge.
§ 868.1030 - Manual algesimeter. § 868.2620 - Gas pressure calibrator.
§ 868.1040 - Powered algesimeter. § 868.2700 - Pressure regulator.
§ 868.1075 - Argon gas analyzer. § 868.2775 - Electrical peripheral nerve stimulator.
§ 868.1100 - Arterial blood sampling kit. § 868.2875 - Differential pressure transducer.
§ 868.1120 - Indwelling blood oxyhemoglobin § 868.2885 - Gas flow transducer.
concentration analyzer. § 868.2900 - Gas pressure transducer.
§ 868.1150 - Indwelling blood carbon dioxide partial Subparts D-E [Reserved]
pressure (PCO2) analyzer. Subpart F--Therapeutic Devices
§ 868.1170 - Indwelling blood hydrogen ion § 868.5090 - Emergency airway needle.
concentration (pH) analyzer. § 868.5100 - Nasopharyngeal airway.
§ 868.1200 - Indwelling blood oxygen partial § 868.5110 - Oropharyngeal airway.
pressure (PO2) analyzer. § 868.5115 - Device to relieve acute upper airway
§ 868.1400 - Carbon dioxide gas analyzer. obstruction.
§ 868.1430 - Carbon monoxide gas analyzer. § 868.5120 - Anesthesia conduction catheter.
§ 868.1500 - Enflurane gas analyzer. § 868.5130 - Anesthesia conduction filter.
§ 868.1575 - Gas collection vessel. § 868.5140 - Anesthesia conduction kit.
§ 868.1620 - Halothane gas analyzer. § 868.5150 - Anesthesia conduction needle.
§ 868.1640 - Helium gas analyzer. § 868.5160 - Gas machine for anesthesia or
§ 868.1670 - Neon gas analyzer. analgesia.
§ 868.1690 - Nitrogen gas analyzer. § 868.5165 - Nitric oxide administration apparatus.
§ 868.1700 - Nitrous oxide gas analyzer. § 868.5170 - Laryngotracheal topical anesthesia
§ 868.1720 - Oxygen gas analyzer. applicator.
§ 868.1730 - Oxygen uptake computer. § 868.5180 - Rocking bed.
§ 868.1750 - Pressure plethysmograph. § 868.5220 - Blow bottle.
§ 868.1760 - Volume plethysmograph. § 868.5240 - Anesthesia breathing circuit.
§ 868.1780 - Inspiratory airway pressure meter. § 868.5250 - Breathing circuit circulator.
§ 868.1800 - Rhinoanemometer. § 868.5260 - Breathing circuit bacterial filter.
§ 868.1840 - Diagnostic spirometer. § 868.5270 - Breathing system heater.
§ 868.1850 - Monitoring spirometer. § 868.5280 - Breathing tube support.
§ 868.1860 - Peak-flow meter for spirometry. § 868.5300 - Carbon dioxide absorbent.
§ 868.1870 - Gas volume calibrator. § 868.5310 - Carbon dioxide absorber.
§ 868.1880 - Pulmonary-function data calculator. § 868.5320 - Reservoir bag.
§ 868.1890 - Predictive pulmonary-function value § 868.5330 - Breathing gas mixer.
calculator. § 868.5340 - Nasal oxygen cannula.
§ 868.1900 - Diagnostic pulmonary-function § 868.5350 - Nasal oxygen catheter.
interpretation calculator. § 868.5365 - Posture chair for cardiac or pulmonary
§ 868.1910 - Esophageal stethoscope. treatment.
§ 868.1920 - Esophageal stethoscope with electrical § 868.5375 - Heat and moisture condenser (artificial
conductors. nose).
§ 868.1930 - Stethoscope head. § 868.5400 - Electroanesthesia apparatus.
§ 868.1965 - Switching valve (ploss). § 868.5420 - Ether hook.
§ 868.1975 - Water vapor analyzer. § 868.5430 - Gas-scavenging apparatus.
Subpart C--Monitoring Devices § 868.5440 - Portable oxygen generator.
§ 868.2025 - Ultrasonic air embolism monitor. § 868.5450 - Respiratory gas humidifier.
§ 868.2300 - Bourdon gauge flowmeter. § 868.5460 - Therapeutic humidifier for home use.
§ 868.2320 - Uncompensated thorpe tube § 868.5470 - Hyperbaric chamber.
flowmeter. § 868.5530 - Flexible laryngoscope.

§ 868.5540 - Rigid laryngoscope. SUBCHAPTER H--MEDICAL DEVICES

§ 868.5550 - Anesthetic gas mask. PART 870
§ 868.5560 - Gas mask head strap. CARDIOVASCULAR DEVICES
§ 868.5570 - Nonrebreathing mask. Subpart A--General Provisions
§ 868.5580 - Oxygen mask. § 870.1 - Scope.
§ 868.5590 - Scavenging mask. § 870.3 - Effective dates of requirement for
§ 868.5600 - Venturi mask. premarket approval.
§ 868.5620 - Breathing mouthpiece. § 870.9 - Limitations of exemptions from section
§ 868.5630 - Nebulizer. 510(k) of the Federal Food, Drug, and Cosmetic Act
§ 868.5640 - Medicinal nonventilatory nebulizer (the act).
(atomizer). Subpart B--Cardiovascular Diagnostic Devices
§ 868.5650 - Esophageal obturator. § 870.1025 - Arrhythmia detector and alarm
§ 868.5655 - Portable liquid oxygen unit. (including ST-segment measurement and alarm).
§ 868.5665 - Powered percussor. § 870.1100 - Blood pressure alarm.
§ 868.5675 - Rebreathing device. § 870.1110 - Blood pressure computer.
§ 868.5690 - Incentive spirometer. § 870.1120 - Blood pressure cuff.
§ 868.5700 - Nonpowered oxygen tent. § 870.1130 - Noninvasive blood pressure
§ 868.5710 - Electrically powered oxygen tent. measurement system.
§ 868.5720 - Bronchial tube. § 870.1140 - Venous blood pressure manometer.
§ 868.5730 - Tracheal tube. § 870.1200 - Diagnostic intravascular catheter.
§ 868.5740 - Tracheal/bronchial differential § 870.1210 - Continuous flush catheter.
ventilation tube. § 870.1220 - Electrode recording catheter or
§ 868.5750 - Inflatable tracheal tube cuff. electrode recording probe.
§ 868.5760 - Cuff spreader. § 870.1230 - Fiberoptic oximeter catheter.
§ 868.5770 - Tracheal tube fixation device. § 870.1240 - Flow-directed catheter.
§ 868.5780 - Tube introduction forceps. § 870.1250 - Percutaneous catheter.
§ 868.5790 - Tracheal tube stylet. § 870.1270 - Intracavitary phonocatheter system.
§ 868.5795 - Tracheal tube cleaning brush. § 870.1280 - Steerable catheter.
§ 868.5800 - Tracheostomy tube and tube cuff. § 870.1290 - Steerable catheter control system.
§ 868.5810 - Airway connector. § 870.1300 - Catheter cannula.
§ 868.5820 - Dental protector. § 870.1310 - Vessel dilator for percutaneous
§ 868.5830 - Autotransfusion apparatus. catheterization.
§ 868.5860 - Pressure tubing and accessories. § 870.1330 - Catheter guide wire.
§ 868.5870 - Nonrebreathing valve. § 870.1340 - Catheter introducer.
§ 868.5880 - Anesthetic vaporizer. § 870.1350 - Catheter balloon repair kit.
§ 868.5895 - Continuous ventilator. § 870.1360 - Trace microsphere.
§ 868.5905 - Noncontinuous ventilator (IPPB). § 870.1370 - Catheter tip occluder.
§ 868.5915 - Manual emergency ventilator. § 870.1380 - Catheter stylet.
§ 868.5925 - Powered emergency ventilator. § 870.1390 - Trocar.
§ 868.5935 - External negative pressure ventilator. § 870.1415 - Coronary vascular physiologic
§ 868.5955 - Intermittent mandatory ventilation simulation software device.
attachment. § 870.1425 - Programmable diagnostic computer.
§ 868.5965 - Positive end expiratory pressure § 870.1435 - Single-function, preprogrammed
breathing attachment. diagnostic computer.
§ 868.5975 - Ventilator tubing. § 870.1450 - Densitometer.
§ 868.5995 - Tee drain (water trap). § 870.1650 - Angiographic injector and syringe.
Subpart G--Miscellaneous § 870.1660 - Indicator injector.
§ 868.6100 - Anesthetic cabinet, table, or tray. § 870.1670 - Syringe actuator for an injector.
§ 868.6175 - Cardiopulmonary emergency cart. § 870.1750 - External programmable pacemaker
§ 868.6225 - Nose clip. pulse generator.
§ 868.6250 - Portable air compressor. § 870.1800 - Withdrawal-infusion pump.
§ 868.6400 - Calibration gas. § 870.1875 - Stethoscope.
§ 868.6700 - Anesthesia stool. § 870.1915 - Thermodilution probe.
§ 868.6810 - Tracheobronchial suction catheter. Subpart C--Cardiovascular Monitoring Devices
§ 868.6820 - Patient position support. § 870.2050 - Biopotential amplifier and signal
§ 868.6885 - Medical gas yoke assembly. conditioner.
§ 870.2060 - Transducer signal amplifier and
TITLE 21--FOOD AND DRUGS conditioner.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 870.2100 - Cardiovascular blood flowmeter.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 870.2120 - Extravascular blood flow probe.
 § 870.2300 - Cardiac monitor (including § 870.3640 - Indirect pacemaker generator function
cardiotachometer and rate alarm). analyzer.
§ 870.2310 - Apex cardiograph (vibrocardiograph). § 870.3650 - Pacemaker polymeric mesh bag.
§ 870.2320 - Ballistocardiograph. § 870.3670 - Pacemaker charger.
§ 870.2330 - Echocardiograph. § 870.3680 - Cardiovascular permanent or temporary
§ 870.2340 - Electrocardiograph. pacemaker electrode.
§ 870.2350 - Electrocardiograph lead switching § 870.3690 - Pacemaker test magnet.
adaptor. § 870.3700 - Pacemaker programmers.
§ 870.2360 - Electrocardiograph electrode. § 870.3710 - Pacemaker repair or replacement
§ 870.2370 - Electrocardiograph surface electrode material.
tester. § 870.3720 - Pacemaker electrode function tester.
§ 870.2390 - Phonocardiograph. § 870.3730 - Pacemaker service tools.
§ 870.2400 - Vectorcardiograph. § 870.3800 - Annuloplasty ring.
§ 870.2450 - Medical cathode-ray tube display. § 870.3850 - Carotid sinus nerve stimulator.
§ 870.2600 - Signal isolation system. § 870.3925 - Replacement heart valve.
§ 870.2620 - Line isolation monitor. § 870.3935 - Prosthetic heart valve holder.
§ 870.2640 - Portable leakage current alarm. § 870.3945 - Prosthetic heart valve sizer.
§ 870.2675 - Oscillometer. Subpart E--Cardiovascular Surgical Devices
§ 870.2700 - Oximeter. § 870.4075 - Endomyocardial biopsy device.
§ 870.2710 - Ear oximeter. § 870.4100 - Extracorporeal circuit and accessories
§ 870.2750 - Impedance phlebograph. for long-term respiratory/cardiopulmonary failure.
§ 870.2770 - Impedance plethysmograph. § 870.4200 - Cardiopulmonary bypass accessory
§ 870.2780 - Hydraulic, pneumatic, or photoelectric equipment.
plethysmographs. § 870.4205 - Cardiopulmonary bypass bubble
§ 870.2800 - Medical magnetic tape recorder. detector.
§ 870.2810 - Paper chart recorder. § 870.4210 - Cardiopulmonary bypass vascular
§ 870.2840 - Apex cardiographic transducer. catheter, cannula, or tubing.
§ 870.2850 - Extravascular blood pressure § 870.4220 - Cardiopulmonary bypass heart-lung
transducer. machine console.
§ 870.2855 - Implantable Intra-aneurysm Pressure § 870.4230 - Cardiopulmonary bypass defoamer.
Measurement System. § 870.4240 - Cardiopulmonary bypass heat
§ 870.2860 - Heart sound transducer. exchanger.
§ 870.2870 - Catheter tip pressure transducer. § 870.4250 - Cardiopulmonary bypass temperature
§ 870.2880 - Ultrasonic transducer. controller.
§ 870.2890 - Vessel occlusion transducer. § 870.4260 - Cardiopulmonary bypass arterial line
§ 870.2900 - Patient transducer and electrode cable blood filter.
(including connector). § 870.4270 - Cardiopulmonary bypass cardiotomy
§ 870.2910 - Radiofrequency physiological signal suction line blood filter.
transmitter and receiver. § 870.4280 - Cardiopulmonary prebypass filter.
§ 870.2920 - Telephone electrocardiograph § 870.4290 - Cardiopulmonary bypass adaptor,
transmitter and receiver. stopcock, manifold, or fitting.
Subpart D--Cardiovascular Prosthetic Devices § 870.4300 - Cardiopulmonary bypass gas control
§ 870.3250 - Vascular clip. unit.
§ 870.3260 - Vena cava clip. § 870.4310 - Cardiopulmonary bypass coronary
§ 870.3300 - Vascular embolization device. pressure gauge.
§ 870.3375 - Cardiovascular intravascular filter. § 870.4320 - Cardiopulmonary bypass pulsatile flow
§ 870.3450 - Vascular graft prosthesis. generator.
§ 870.3460 - Endovascular Suturing System. § 870.4330 - Cardiopulmonary bypass on-line blood
§ 870.3470 - Intracardiac patch or pledget made of gas monitor.
polypropylene, polyethylene terephthalate, or § 870.4340 - Cardiopulmonary bypass level sensing
polytetrafluoroethylene. monitor and/or control.
§ 870.3535 - Intra-aortic balloon and control system. § 870.4350 - Cardiopulmonary bypass oxygenator.
§ 870.3545 - Ventricular bypass (assist) device. § 870.4360 - Nonroller-type blood pump.
§ 870.3600 - External pacemaker pulse generator. § 870.4370 - Roller-type cardiopulmonary bypass
§ 870.3605 - Pacing system analyzer. blood pump.
§ 870.3610 - Implantable pacemaker pulse § 870.4380 - Cardiopulmonary bypass pump speed
generator. control.
§ 870.3620 - Pacemaker lead adaptor. § 870.4390 - Cardiopulmonary bypass pump tubing.
§ 870.3630 - Pacemaker generator function § 870.4400 - Cardiopulmonary bypass blood
analyzer. reservoir.

§ 870.4410 - Cardiopulmonary bypass in-line blood § 862.1050 - Alkaline phosphatase or isoenzymes

gas sensor. test system.
§ 870.4420 - Cardiopulmonary bypass cardiotomy § 862.1055 - Newborn screening test system for
return sucker. amino acids, free carnitine, and acylcarnitines using
§ 870.4430 - Cardiopulmonary bypass intracardiac tandem mass spectrometry.
suction control. § 862.1060 - Delta-aminolevulinic acid test system.
§ 870.4450 - Vascular clamp. § 862.1065 - Ammonia test system.
§ 870.4475 - Surgical vessel dilator. § 862.1070 - Amylase test system.
§ 870.4500 - Cardiovascular surgical instruments. § 862.1075 - Androstenedione test system.
§ 870.4510 - Apical closure device. § 862.1080 - Androsterone test system.
§ 870.4875 - Intraluminal artery stripper. § 862.1085 - Angiotensin I and renin test system.
§ 870.4885 - External vein stripper. § 862.1090 - Angiotensin converting enzyme (A.C.E.)
Subpart F--Cardiovascular Therapeutic Devices test system.
§ 870.5050 - Patient care suction apparatus. § 862.1095 - Ascorbic acid test system.
§ 870.5100 - Percutaneous Transluminal Coronary § 862.1100 - Aspartate amino transferase
Angioplasty (PTCA) Catheter. (AST/SGOT) test system.
§ 870.5150 - Embolectomy catheter. § 862.1110 - Bilirubin (total or direct) test system.
§ 870.5175 - Septostomy catheter. § 862.1113 - Bilirubin (total and unbound) in the
§ 870.5200 - External cardiac compressor. neonate test system.
§ 870.5210 - Cardiopulmonary resuscitation (CPR) § 862.1115 - Urinary bilirubin and its conjugates
aid. (nonquantitative) test system.
§ 870.5225 - External counter-pulsating device. § 862.1117 - B-type natriuretic peptide test system.
§ 870.5300 - DC-defibrillator (including paddles). § 862.1118 - Biotinidase test system.
§ 870.5310 - Automated external defibrillator § 862.1120 - Blood gases (PCO2, PO2) and blood pH
system. test system.
§ 870.5325 - Defibrillator tester. § 862.1130 - Blood volume test system.
§ 870.5550 - External transcutaneous cardiac § 862.1135 - C-peptides of proinsulin test system.
pacemaker (noninvasive). § 862.1140 - Calcitonin test system.
§ 870.5700 - Steerable cardiac ablation catheter § 862.1145 - Calcium test system.
remote control system. § 862.1150 - Calibrator.
§ 870.5800 - Compressible limb sleeve. § 862.1155 - Human chorionic gonadotropin (HCG)
§ 870.5900 - Thermal regulating system. test system.
§ 870.5910 - Esophageal thermal regulation device. § 862.1160 - Bicarbonate/carbon dioxide test
§ 870.5925 - Automatic rotating tourniquet. system.
§ 862.1163 - Cardiac allograft gene expression
TITLE 21--FOOD AND DRUGS profiling test system.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 862.1165 - Catecholamines (total) test system.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 862.1170 - Chloride test system.
SUBCHAPTER H--MEDICAL DEVICES § 862.1175 - Cholesterol (total) test system.
PART 862 § 862.1177 - Cholylglycine test system.
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY § 862.1180 - Chymotrypsin test system.
DEVICES § 862.1185 - Compound S (11-deoxycortisol) test
Subpart A--General Provisions system.
§ 862.1 - Scope. § 862.1187 - Conjugated sulfolithocholic acid (SLCG)
§ 862.2 - Regulation of calibrators. test system.
§ 862.3 - Effective dates of requirement for § 862.1190 - Copper test system.
premarket approval. § 862.1195 - Corticoids test system.
§ 862.9 - Limitations of exemptions from section § 862.1200 - Corticosterone test system.
510(k) of the Federal Food, Drug, and Cosmetic Act § 862.1205 - Cortisol (hydrocortisone and
(the act). hydroxycorticosterone) test system.
Subpart B--Clinical Chemistry Test Systems § 862.1210 - Creatine test system.
§ 862.1020 - Acid phosphatase (total or prostatic) § 862.1215 - Creatine phosphokinase/creatine kinase
test system. or isoenzymes test system.
§ 862.1025 - Adrenocorticotropic hormone (ACTH) § 862.1225 - Creatinine test system.
test system. § 862.1230 - Cyclic AMP test system.
§ 862.1030 - Alanine amino transferase (ALT/SGPT) § 862.1235 - Cyclosporine test system.
test system. § 862.1240 - Cystine test system.
§ 862.1035 - Albumin test system. § 862.1245 - Dehydroepiandrosterone (free and
§ 862.1040 - Aldolase test system. sulfate) test system.
§ 862.1045 - Aldosterone test system. § 862.1250 - Desoxycorticosterone test system.
 § 862.1255 - 2,3-Diphosphoglyceric acid test system. § 862.1490 - Lysozyme (muramidase) test system.
§ 862.1260 - Estradiol test system. § 862.1495 - Magnesium test system.
§ 862.1265 - Estriol test system. § 862.1500 - Malic dehydrogenase test system.
§ 862.1270 - Estrogens (total, in pregnancy) test § 862.1505 - Mucopolysaccharides (nonquantitative)
system. test system.
§ 862.1275 - Estrogens (total, nonpregnancy) test § 862.1509 - Methylmalonic acid (nonquantitative)
system. test system.
§ 862.1280 - Estrone test system. § 862.1510 - Nitrite (nonquantitative) test system.
§ 862.1285 - Etiocholanolone test system. § 862.1515 - Nitrogen (amino-nitrogen) test system.
§ 862.1290 - Fatty acids test system. § 862.1520 - 5'-Nucleotidase test system.
§ 862.1295 - Folic acid test system. § 862.1530 - Plasma oncometry test system.
§ 862.1300 - Follicle-stimulating hormone test § 862.1535 - Ornithine carbamyl transferase test
system. system.
§ 862.1305 - Formiminoglutamic acid (FIGLU) test § 862.1540 - Osmolality test system.
system. § 862.1542 - Oxalate test system.
§ 862.1310 - Galactose test system. § 862.1545 - Parathyroid hormone test system.
§ 862.1315 - Galactose-1-phosphate uridyl § 862.1550 - Urinary pH (nonquantitative) test
transferase test system. system.
§ 862.1320 - Gastric acidity test system. § 862.1555 - Phenylalanine test system.
§ 862.1325 - Gastrin test system. § 862.1560 - Urinary phenylketones
§ 862.1330 - Globulin test system. (nonquantitative) test system.
§ 862.1335 - Glucagon test system. § 862.1565 - 6-Phosphogluconate dehydrogenase
§ 862.1340 - Urinary glucose (nonquantitative) test test system.
system. § 862.1570 - Phosphohexose isomerase test system.
§ 862.1345 - Glucose test system. § 862.1575 - Phospholipid test system.
§ 862.1350 - Continuous glucose monitor secondary § 862.1580 - Phosphorus (inorganic) test system.
display. § 862.1585 - Human placental lactogen test system.
§ 862.1360 - Gamma-glutamyl transpeptidase and § 862.1590 - Porphobilinogen test system.
isoenzymes test system. § 862.1595 - Porphyrins test system.
§ 862.1365 - Glutathione test system. § 862.1600 - Potassium test system.
§ 862.1370 - Human growth hormone test system. § 862.1605 - Pregnanediol test system.
§ 862.1373 - Hemoglobin A1c test system. § 862.1610 - Pregnanetriol test system.
§ 862.1375 - Histidine test system. § 862.1615 - Pregnenolone test system.
§ 862.1377 - Urinary homocystine (nonquantitative) § 862.1620 - Progesterone test system.
test system. § 862.1625 - Prolactin (lactogen) test system.
§ 862.1380 - Hydroxybutyric dehydrogenase test § 862.1630 - Protein (fractionation) test system.
system. § 862.1635 - Total protein test system.
§ 862.1385 - 17-Hydroxycorticosteroids (17- § 862.1640 - Protein-bound iodine test system.
ketogenic steroids) test system. § 862.1645 - Urinary protein or albumin
§ 862.1390 - 5-Hydroxyindole acetic acid/serotonin (nonquantitative) test system.
test system. § 862.1650 - Pyruvate kinase test system.
§ 862.1395 - 17-Hydroxyprogesterone test system. § 862.1655 - Pyruvic acid test system.
§ 862.1400 - Hydroxyproline test system. § 862.1660 - Quality control material (assayed and
§ 862.1405 - Immunoreactive insulin test system. unassayed).
§ 862.1410 - Iron (non-heme) test system. § 862.1665 - Sodium test system.
§ 862.1415 - Iron-binding capacity test system. § 862.1670 - Sorbitol dehydrogenase test system.
§ 862.1420 - Isocitric dehydrogenase test system. § 862.1675 - Blood specimen collection device.
§ 862.1430 - 17-Ketosteroids test system. § 862.1678 - Tacrolimus test system.
§ 862.1435 - Ketones (nonquantitative) test system. § 862.1680 - Testosterone test system.
§ 862.1440 - Lactate dehydrogenase test system. § 862.1685 - Thyroxine-binding globulin test system.
§ 862.1445 - Lactate dehydrogenase isoenzymes test § 862.1690 - Thyroid stimulating hormone test
system. system.
§ 862.1450 - Lactic acid test system. § 862.1695 - Free thyroxine test system.
§ 862.1455 - Lecithin/sphingomyelin ratio in amniotic § 862.1700 - Total thyroxine test system.
fluid test system. § 862.1705 - Triglyceride test system.
§ 862.1460 - Leucine aminopeptidase test system. § 862.1710 - Total triiodothyronine test system.
§ 862.1465 - Lipase test system. § 862.1715 - Triiodothyronine uptake test system.
§ 862.1470 - Lipid (total) test system. § 862.1720 - Triose phosphate isomerase test
§ 862.1475 - Lipoprotein test system. system.
§ 862.1485 - Luteinizing hormone test system. § 862.1725 - Trypsin test system.

§ 862.1730 - Free tyrosine test system. § 862.2860 - Mass spectrometer for clinical use.
§ 862.1770 - Urea nitrogen test system. § 862.2900 - Automated urinalysis system.
§ 862.1775 - Uric acid test system. § 862.2920 - Plasma viscometer for clinical use.
§ 862.1780 - Urinary calculi (stones) test system. Subpart D--Clinical Toxicology Test Systems
§ 862.1785 - Urinary urobilinogen (nonquantitative) § 862.3030 - Acetaminophen test system.
test system. § 862.3035 - Amikacin test system.
§ 862.1790 - Uroporphyrin test system. § 862.3040 - Alcohol test system.
§ 862.1795 - Vanilmandelic acid test system. § 862.3050 - Breath-alcohol test system.
§ 862.1805 - Vitamin A test system. § 862.3080 - Breath nitric oxide test system.
§ 862.1810 - Vitamin B[bdi1][bdi2] test system. § 862.3100 - Amphetamine test system.
§ 862.1815 - Vitamin E test system. § 862.3110 - Antimony test system.
§ 862.1820 - Xylose test system. § 862.3120 - Arsenic test system.
§ 862.1825 - Vitamin D test system. § 862.3150 - Barbiturate test system.
Subpart C--Clinical Laboratory Instruments § 862.3170 - Benzodiazepine test system.
§ 862.2050 - General purpose laboratory equipment § 862.3200 - Clinical toxicology calibrator.
labeled or promoted for a specific medical use. § 862.3220 - Carbon monoxide test system.
§ 862.2100 - Calculator/data processing module for § 862.3240 - Cholinesterase test system.
clinical use. § 862.3250 - Cocaine and cocaine metabolite test
§ 862.2140 - Centrifugal chemistry analyzer for system.
clinical use. § 862.3270 - Codeine test system.
§ 862.2150 - Continuous flow sequential multiple § 862.3280 - Clinical toxicology control material.
chemistry analyzer for clinical use. § 862.3300 - Digitoxin test system.
§ 862.2160 - Discrete photometric chemistry § 862.3320 - Digoxin test system.
analyzer for clinical use. § 862.3350 - Diphenylhydantoin test system.
§ 862.2170 - Micro chemistry analyzer for clinical § 862.3360 - Drug metabolizing enzyme genotyping
use. system.
§ 862.2230 - Chromatographic separation material § 862.3380 - Ethosuximide test system.
for clinical use. § 862.3450 - Gentamicin test system.
§ 862.2250 - Gas liquid chromatography system for § 862.3520 - Kanamycin test system.
clinical use. § 862.3550 - Lead test system.
§ 862.2260 - High pressure liquid chromatography § 862.3555 - Lidocaine test system.
system for clinical use. § 862.3560 - Lithium test system.
§ 862.2265 - High throughput genomic sequence § 862.3580 - Lysergic acid diethylamide (LSD) test
analyzer for clinical use. system.
§ 862.2270 - Thin-layer chromatography system for § 862.3600 - Mercury test system.
clinical use. § 862.3610 - Methamphetamine test system.
§ 862.2300 - Colorimeter, photometer, or § 862.3620 - Methadone test system.
spectrophotometer for clinical use. § 862.3630 - Methaqualone test system.
§ 862.2310 - Clinical sample concentrator. § 862.3640 - Morphine test system.
§ 862.2320 - Beta or gamma counter for clinical use. § 862.3645 - Neuroleptic drugs radioreceptor assay
§ 862.2400 - Densitometer/scanner (integrating, test system.
reflectance, TLC, or radiochromatogram) for clinical § 862.3650 - Opiate test system.
use. § 862.3660 - Phenobarbital test system.
§ 862.2485 - Electrophoresis apparatus for clinical § 862.3670 - Phenothiazine test system.
use. § 862.3680 - Primidone test system.
§ 862.2500 - Enzyme analyzer for clinical use. § 862.3700 - Propoxyphene test system.
§ 862.2540 - Flame emission photometer for clinical § 862.3750 - Quinine test system.
use. § 862.3830 - Salicylate test system.
§ 862.2560 - Fluorometer for clinical use. § 862.3840 - Sirolimus test system.
§ 862.2570 - Instrumentation for clinical multiplex § 862.3850 - Sulfonamide test system.
test systems. § 862.3870 - Cannabinoid test system.
§ 862.2680 - Microtitrator for clinical use. § 862.3880 - Theophylline test system.
§ 862.2700 - Nephelometer for clinical use. § 862.3900 - Tobramycin test system.
§ 862.2720 - Plasma oncometer for clinical use. § 862.3910 - Tricyclic antidepressant drugs test
§ 862.2730 - Osmometer for clinical use. system.
§ 862.2750 - Pipetting and diluting system for clinical § 862.3950 - Vancomycin test system.
use.
§ 862.2800 - Refractometer for clinical use. TITLE 21--FOOD AND DRUGS
§ 862.2850 - Atomic absorption spectrophotometer CHAPTER I--FOOD AND DRUG ADMINISTRATION
for clinical use. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 SUBCHAPTER H--MEDICAL DEVICES § 872.3480 - Polyacrylamide polymer (modified
PART 872 cationic) denture adhesive.
DENTAL DEVICES § 872.3490 - Carboxymethylcellulose sodium and/or
Subpart A--General Provisions polyvinylmethylether maleic acid calcium-sodium
§ 872.1 - Scope. double salt denture adhesive.
§ 872.3 - Effective dates of requirement for § 872.3500 - Polyvinylmethylether maleic anhydride
premarket approval. (PVM-MA), acid copolymer, and
§ 872.9 - Limitations of exemptions from section carboxymethylcellulose sodium (NACMC) denture
510(k) of the Federal Food, Drug, and Cosmetic Act adhesive.
(the act). § 872.3520 - OTC denture cleanser.
Subpart B--Diagnostic Devices § 872.3530 - Mechanical denture cleaner.
§ 872.1500 - Gingival fluid measurer. § 872.3540 - OTC denture cushion or pad.
§ 872.1720 - Pulp tester. § 872.3560 - OTC denture reliner.
§ 872.1730 - Electrode gel for pulp testers. § 872.3570 - OTC denture repair kit.
§ 872.1740 - Caries detection device. § 872.3580 - Preformed gold denture tooth.
§ 872.1745 - Laser fluorescence caries detection § 872.3590 - Preformed plastic denture tooth.
device. § 872.3600 - Partially fabricated denture kit.
§ 872.1800 - Extraoral source x-ray system. § 872.3630 - Endosseous dental implant abutment.
§ 872.1810 - Intraoral source x-ray system. § 872.3640 - Endosseous dental implant.
§ 872.1820 - Dental x-ray exposure alignment § 872.3645 - Subperiosteal implant material.
device. § 872.3660 - Impression material.
§ 872.1830 - Cephalometer. § 872.3661 - Optical Impression Systems for
§ 872.1840 - Dental x-ray position indicating device. CAD/CAM.
§ 872.1850 - Lead-lined position indicator. § 872.3670 - Resin impression tray material.
§ 872.1870 - Sulfide detection device. § 872.3680 - Polytetrafluoroethylene (PTFE) vitreous
§ 872.1905 - Dental x-ray film holder. carbon materials.
§ 872.2050 - Dental sonography device. § 872.3690 - Tooth shade resin material.
§ 872.2060 - Jaw tracking device. § 872.3710 - Base metal alloy.
Subpart C [Reserved] § 872.3730 - Pantograph.
Subpart D--Prosthetic Devices § 872.3740 - Retentive and splinting pin.
§ 872.3060 - Noble metal alloy. § 872.3750 - Bracket adhesive resin and tooth
§ 872.3070 - Dental amalgam, mercury, and conditioner.
amalgam alloy. § 872.3760 - Denture relining, repairing, or rebasing
§ 872.3080 - Mercury and alloy dispenser. resin.
§ 872.3100 - Dental amalgamator. § 872.3765 - Pit and fissure sealant and conditioner.
§ 872.3110 - Dental amalgam capsule. § 872.3770 - Temporary crown and bridge resin.
§ 872.3130 - Preformed anchor. § 872.3810 - Root canal post.
§ 872.3140 - Resin applicator. § 872.3820 - Root canal filling resin.
§ 872.3150 - Articulator. § 872.3830 - Endodontic paper point.
§ 872.3165 - Precision attachment. § 872.3840 - Endodontic silver point.
§ 872.3200 - Resin tooth bonding agent. § 872.3850 - Gutta percha.
§ 872.3220 - Facebow. § 872.3890 - Endodontic stabilizing splint.
§ 872.3240 - Dental bur. § 872.3900 - Posterior artificial tooth with a metal
§ 872.3250 - Calcium hydroxide cavity liner. insert.
§ 872.3260 - Cavity varnish. § 872.3910 - Backing and facing for an artificial
§ 872.3275 - Dental cement. tooth.
§ 872.3285 - Preformed clasp. § 872.3920 - Porcelain tooth.
§ 872.3300 - Hydrophilic resin coating for dentures. § 872.3930 - Bone grafting material.
§ 872.3310 - Coating material for resin fillings. § 872.3940 - Total temporomandibular joint
§ 872.3330 - Preformed crown. prosthesis.
§ 872.3350 - Gold or stainless steel cusp. § 872.3950 - Glenoid fossa prosthesis.
§ 872.3360 - Preformed cusp. § 872.3960 - Mandibular condyle prosthesis.
§ 872.3400 - Karaya and sodium borate with or § 872.3970 - Interarticular disc prosthesis
without acacia denture adhesive. (interpositional implant).
§ 872.3410 - Ethylene oxide homopolymer and/or § 872.3980 - Endosseous dental implant accessories.
carboxymethylcellulose sodium denture adhesive. Subpart E--Surgical Devices
§ 872.3420 - Carboxymethylcellulose sodium and § 872.4120 - Bone cutting instrument and
cationic polyacrylamide polymer denture adhesive. accessories.
§ 872.4130 - Intraoral dental drill.
§ 872.3450 - Ethylene oxide homopolymer and/or
§ 872.4200 - Dental handpiece and accessories.
karaya denture adhesive.
§ 872.4465 - Gas-powered jet injector.

§ 872.4475 - Spring-powered jet injector. SUBCHAPTER H--MEDICAL DEVICES

§ 872.4535 - Dental diamond instrument. PART 874 EAR,
§ 872.4565 - Dental hand instrument. NOSE, AND THROAT DEVICES
§ 872.4600 - Intraoral ligature and wire lock. Subpart A--General Provisions
§ 872.4620 - Fiber optic dental light. § 874.1 - Scope.
§ 872.4630 - Dental operating light. § 874.3 - Effective dates of requirement for
§ 872.4730 - Dental injecting needle. premarket approval.
§ 872.4760 - Bone plate. § 874.9 - Limitations of exemptions from section
§ 872.4770 - Temporary mandibular condyle 510(k) of the Federal Food, Drug, and Cosmetic Act
reconstruction plate. (the act).
§ 872.4840 - Rotary scaler. Subpart B--Diagnostic Devices
§ 872.4850 - Ultrasonic scaler. § 874.1050 - Audiometer.
§ 872.4880 - Intraosseous fixation screw or wire. § 874.1060 - Acoustic chamber for audiometric
§ 872.4920 - Dental electrosurgical unit and testing.
accessories. § 874.1070 - Short increment sensitivity index (SISI)
Subpart F--Therapeutic Devices adapter.
§ 872.5410 - Orthodontic appliance and accessories. § 874.1080 - Audiometer calibration set.
§ 872.5470 - Orthodontic plastic bracket. § 874.1090 - Auditory impedance tester.
§ 872.5500 - Extraoral orthodontic headgear. § 874.1100 - Earphone cushion for audiometric
§ 872.5525 - Preformed tooth positioner. testing.
§ 872.5550 - Teething ring. § 874.1120 - Electronic noise generator for
§ 872.5560 - Electrical salivary stimulatory system. audiometric testing.
§ 872.5570 - Intraoral devices for snoring and § 874.1325 - Electroglottograph.
intraoral devices for snoring and obstructive sleep § 874.1500 - Gustometer.
apnea. § 874.1600 - Olfactory test device.
§ 872.5580 - Oral rinse to reduce the adhesion of § 874.1800 - Air or water caloric stimulator.
dental plaque. § 874.1820 - Surgical nerve stimulator/locator.
Subpart G--Miscellaneous Devices § 874.1925 - Toynbee diagnostic tube.
§ 872.6010 - Abrasive device and accessories. Subpart C [Reserved]
§ 872.6030 - Oral cavity abrasive polishing agent. Subpart D--Prosthetic Devices
§ 872.6050 - Saliva absorber. § 874.3320 - Group hearing aid or group auditory
§ 872.6070 - Ultraviolet activator for polymerization. trainer.
§ 872.6080 - Airbrush. § 874.3330 - Master hearing aid.
§ 872.6100 - Anesthetic warmer. § 874.3375 - Battery-powered artificial larynx.
§ 872.6140 - Articulation paper. § 874.3400 - Tinnitus masker.
§ 872.6200 - Base plate shellac. § 874.3430 - Middle ear mold.
§ 872.6250 - Dental chair and accessories. § 874.3450 - Partial ossicular replacement
§ 872.6290 - Prophylaxis cup. prosthesis.
§ 872.6300 - Rubber dam and accessories. § 874.3495 - Total ossicular replacement prosthesis.
§ 872.6350 - Ultraviolet detector. § 874.3540 - Prosthesis modification instrument for
§ 872.6390 - Dental floss. ossicular replacement surgery.
§ 872.6475 - Heat source for bleaching teeth. § 874.3620 - Ear, nose, and throat synthetic polymer
§ 872.6510 - Oral irrigation unit. material.
§ 872.6570 - Impression tube. § 874.3695 - Mandibular implant facial prosthesis.
§ 872.6640 - Dental operative unit and accessories. § 874.3730 - Laryngeal prosthesis (Taub design).
§ 872.6650 - Massaging pick or tip for oral hygiene. § 874.3760 - Sacculotomy tack (Cody tack)
§ 872.6660 - Porcelain powder for clinical use. § 874.3820 - Endolymphatic shunt.
§ 872.6670 - Silicate protector. § 874.3850 - Endolymphatic shunt tube with valve.
§ 872.6710 - Boiling water sterilizer. § 874.3880 - Tympanostomy tube.
§ 872.6730 - Endodontic dry heat sterilizer. § 874.3900 - Nasal dilator.
§ 872.6770 - Cartridge syringe. § 874.3930 - Tympanostomy tube with
§ 872.6855 - Manual toothbrush. semipermeable membrane.
§ 872.6865 - Powered toothbrush. § 874.3950 - Transcutaneous air conduction hearing
§ 872.6870 - Disposable fluoride tray. aid system.
§ 872.6880 - Preformed impression tray. § 874.3300 - Hearing Aid.
§ 872.6890 - Intraoral dental wax. § 874.3305 - Wireless air-conduction hearing aid.
§ 874.3310 - Hearing aid calibrator and analysis
TITLE 21--FOOD AND DRUGS system.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 874.3315 - Tympanic membrane contact hearing
aid.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Subpart E--Surgical Devices
 § 874.4100 - Epistaxis balloon. § 876.1620 - Urodynamics measurement system.
§ 874.4140 - Ear, nose, and throat bur. § 876.1725 - Gastrointestinal motility monitoring
§ 874.4175 - Nasopharyngeal catheter. system.
§ 874.4180 - Eustachian tube balloon dilation § 876.1735 - Electrogastrography system.
system. § 876.1800 - Urine flow or volume measuring system.
§ 874.4250 - Ear, nose, and throat electric or Subpart C--Monitoring Devices
pneumatic surgical drill. § 876.2040 - Enuresis alarm.
§ 874.4350 - Ear, nose, and throat fiberoptic light § 876.2050 - Prostate lesion documentation system.
source and carrier. Subpart D--Prosthetic Devices
§ 874.4420 - Ear, nose, and throat manual surgical § 876.3350 - Penile inflatable implant.
instrument. § 876.3630 - Penile rigidity implant.
§ 874.4490 - Argon laser for otology, rhinology, and § 876.3750 - Testicular prosthesis.
laryngology. Subpart E--Surgical Devices
§ 874.4500 - Ear, nose, and throat microsurgical § 876.4020 - Fiberoptic light ureteral catheter.
carbon dioxide laser. § 876.4270 - Colostomy rod.
§ 874.4680 - Bronchoscope (flexible or rigid) and § 876.4300 - Endoscopic electrosurgical unit and
accessories. accessories.
§ 874.4710 - Esophagoscope (flexible or rigid) and § 876.4370 - Gastroenterology-urology evacuator.
accessories. § 876.4400 - Hemorrhoidal ligator.
§ 874.4720 - Mediastinoscope and accessories. § 876.4480 - Electrohydraulic lithotriptor.
§ 874.4750 - Laryngostroboscope. § 876.4500 - Mechanical lithotriptor.
§ 874.4760 - Nasopharyngoscope (flexible or rigid) § 876.4530 - Gastroenterology-urology fiberoptic
and accessories. retractor.
§ 874.4770 - Otoscope. § 876.4560 - Ribdam.
§ 874.4780 - Intranasal splint. § 876.4590 - Interlocking urethral sound.
§ 874.4800 - Bone particle collector. § 876.4620 - Ureteral stent.
Subpart F--Therapeutic Devices § 876.4650 - Water jet renal stone dislodger system.
§ 874.5220 - Ear, nose, and throat drug § 876.4680 - Ureteral stone dislodger.
administration device. § 876.4730 - Manual gastroenterology-urology
§ 874.5300 - Ear, nose, and throat examination and surgical instrument and accessories.
treatment unit. § 876.4770 - Urethrotome.
§ 874.5350 - Suction antichoke device. § 876.4890 - Urological table and accessories.
§ 874.5370 - Tongs antichoke device. Subpart F--Therapeutic Devices
§ 874.5550 - Powered nasal irrigator. § 876.5010 - Biliary catheter and accessories.
§ 874.5800 - External nasal splint. § 876.5011 - Metallic biliary stent system for benign
§ 874.5840 - Antistammering device. strictures.
§ 874.5900 - External upper esophageal sphincter § 876.5015 - Pancreatic drainage stent and delivery
compression device. system.
§ 876.5020 - External penile rigidity devices.
TITLE 21--FOOD AND DRUGS § 876.5025 - Vibrator for climax control of premature
CHAPTER I--FOOD AND DRUG ADMINISTRATION ejaculation.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 876.5030 - Continent ileostomy catheter.
SUBCHAPTER H--MEDICAL DEVICES § 876.5090 - Suprapubic urological catheter and
PART 876 accessories.
GASTROENTEROLOGY-UROLOGY DEVICES § 876.5130 - Urological catheter and accessories.
Subpart A--General Provisions § 876.5140 - Urethral insert with pump for bladder
§ 876.1 - Scope. drainage.
§ 876.3 - Effective dates of requirement for § 876.5160 - Urological clamp for males.
premarket approval. § 876.5210 - Enema kit.
§ 876.9 - Limitations of exemptions from section § 876.5220 - Colonic irrigation system.
510(k) of the Federal Food, Drug, and Cosmetic Act § 876.5250 - Urine collector and accessories.
(the act). § 876.5270 - Implanted electrical urinary continence
Subpart B--Diagnostic Devices device.
§ 876.1075 - Gastroenterology-urology biopsy § 876.5280 - Implanted mechanical/hydraulic urinary
instrument. continence device.
§ 876.1300 - Ingestible telemetric gastrointestinal § 876.5310 - Nonimplanted, peripheral electrical
capsule imaging system. continence device.
§ 876.1330 - Colon capsule endoscopy system. § 876.5320 - Nonimplanted electrical continence
§ 876.1400 - Stomach pH electrode. device.
§ 876.1500 - Endoscope and accessories. § 876.5365 - Esophageal dilator.

§ 876.5450 - Rectal dilator. § 878.3800 - External aesthetic restoration

§ 876.5470 - Ureteral dilator. prosthesis.
§ 876.5520 - Urethral dilator. § 878.3900 - Inflatable extremity splint.
§ 876.5530 - Implantable transprostatic tissue § 878.3910 - Noninflatable extremity splint.
retractor system. § 878.3925 - Plastic surgery kit and accessories.
§ 876.5540 - Blood access device and accessories. Subpart E--Surgical Devices
§ 876.5600 - Sorbent regenerated dialysate delivery § 878.4010 - Tissue adhesive.
system for hemodialysis. § 878.4011 - Tissue adhesive with adjunct wound
§ 876.5630 - Peritoneal dialysis system and closure device for topical approximation of skin.
accessories. § 878.4014 - Nonresorbable gauze/sponge for
§ 876.5665 - Water purification system for external use.
hemodialysis. § 878.4015 - Wound dressing with poly (diallyl
§ 876.5820 - Hemodialysis system and accessories. dimethyl ammonium chloride) (pDADMAC) additive.
§ 876.5830 - Hemodialyzer with disposable insert § 878.4018 - Hydrophilic wound dressing.
(Kiil type). § 878.4020 - Occlusive wound dressing.
§ 876.5860 - High permeability hemodialysis system. § 878.4022 - Hydrogel wound dressing and burn
§ 876.5870 - Sorbent hemoperfusion system. dressing.
§ 876.5880 - Isolated kidney perfusion and transport § 878.4025 - Silicone sheeting.
system and accessories. § 878.4040 - Surgical apparel.
§ 876.5885 - Tissue culture media for human ex vivo § 878.4100 - Organ bag.
tissue and cell culture processing applications. § 878.4160 - Surgical camera and accessories.
§ 876.5895 - Ostomy irrigator. § 878.4200 - Introduction/drainage catheter and
§ 876.5900 - Ostomy pouch and accessories. accessories.
§ 876.5920 - Protective garment for incontinence. § 878.4300 - Implantable clip.
§ 876.5930 - Rectal control system. § 878.4320 - Removable skin clip.
§ 876.5955 - Peritoneo-venous shunt. § 878.4340 - Contact cooling system for aesthetic
§ 876.5970 - Hernia support. use.
§ 876.5980 - Gastrointestinal tube and accessories. § 878.4350 - Cryosurgical unit and accessories.
§ 876.5990 - Extracorporeal shock wave lithotripter. § 878.4360 - Scalp cooling system to reduce the
likelihood of chemotherapy-induced alopecia.
TITLE 21--FOOD AND DRUGS § 878.4370 - Surgical drape and drape accessories.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 878.4380 - Drape adhesive.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 878.4400 - Electrosurgical cutting and coagulation
SUBCHAPTER H--MEDICAL DEVICES device and accessories.
PART 878 § 878.4410 - Low energy ultrasound wound cleaner.
GENERAL AND PLASTIC SURGERY DEVICES § 878.4420 - Electrosurgical device for over-the-
Subpart A--General Provisions counter aesthetic use.
§ 878.1 - Scope. § 878.4440 - Eye pad.
§ 878.3 - Effective dates of requirement for § 878.4450 - Nonabsorbable gauze for internal use.
premarket approval. § 878.4452 - Nonabsorbable expandable hemostatic
§ 878.9 - Limitations of exemptions from section sponge for temporary internal use.
510(k) of the Federal Food, Drug, and Cosmetic Act § 878.4460 - Non-powdered surgeon's glove.
(the act). § 878.4470 - Surgeon's gloving cream.
Subpart B--Diagnostic Devices § 878.4490 - Absorbable hemostatic agent and
§ 878.1800 - Speculum and accessories. dressing.
Subpart C [Reserved] § 878.4493 - Absorbable poly(glycolide/l-lactide)
Subpart D--Prosthetic Devices surgical suture.
§ 878.3250 - External facial fracture fixation § 878.4494 - Absorbable poly(hydroxybutyrate)
appliance. surgical suture produced by recombinant DNA
§ 878.3300 - Surgical mesh. technology.
§ 878.3500 - Polytetrafluoroethylene with carbon § 878.4495 - Stainless steel suture.
fibers composite implant material. § 878.4520 - Polytetrafluoroethylene injectable.
§ 878.3530 - Silicone inflatable breast prosthesis. § 878.4580 - Surgical lamp.
§ 878.3540 - Silicone gel-filled breast prosthesis. § 878.4590 - Focused ultrasound stimulator system
§ 878.3550 - Chin prosthesis. for aesthetic use.
§ 878.3590 - Ear prosthesis. § 878.4630 - Ultraviolet lamp for dermatologic
§ 878.3610 - Esophageal prosthesis. disorders.
§ 878.3680 - Nose prosthesis. § 878.4635 - Sunlamp products and ultraviolet lamps
§ 878.3720 - Tracheal prosthesis. intended for use in sunlamp products.
§ 878.3750 - External prosthesis adhesive. § 878.4660 - Skin marker.
 § 878.4670 - Internal tissue marker. § 880.3 - Effective dates of requirement for
§ 878.4680 - Nonpowered, single patient, portable premarket approval.
suction apparatus. § 880.9 - Limitations of exemptions from section
§ 878.4683 - Non-Powered suction apparatus device 510(k) of the Federal Food, Drug, and Cosmetic Act
intended for negative pressure wound therapy. (the act).
§ 878.4700 - Surgical microscope and accessories. Subpart B [Reserved]
§ 878.4730 - Surgical skin degreaser or adhesive tape Subpart C--General Hospital and Personal Use
solvent. Monitoring Devices
§ 878.4750 - Implantable staple. § 880.2200 - Liquid crystal forehead temperature
§ 878.4755 - Absorbable lung biopsy plug. strip.
§ 878.4760 - Removable skin staple. § 880.2400 - Bed-patient monitor.
§ 878.4780 - Powered suction pump. § 880.2420 - Electronic monitor for gravity flow
§ 878.4790 - Powered surgical instrument for infusion systems.
improvement in the appearance of cellulite. § 880.2460 - Electrically powered spinal fluid
§ 878.4800 - Manual surgical instrument for general pressure monitor.
use. § 880.2500 - Spinal fluid manometer.
§ 878.4810 - Laser surgical instrument for use in § 880.2700 - Stand-on patient scale.
general and plastic surgery and in dermatology. § 880.2720 - Patient scale.
§ 878.4815 - Magnetic surgical instrument system. § 880.2740 - Surgical sponge scale.
§ 878.4820 - Surgical instrument motors and § 880.2800 - Sterilization process indicator.
accessories/attachments. § 880.2900 - Clinical color change thermometer.
§ 878.4830 - Absorbable surgical gut suture. § 880.2910 - Clinical electronic thermometer.
§ 878.4840 - Absorbable polydioxanone surgical § 880.2920 - Clinical mercury thermometer.
suture. § 880.2930 - Apgar timer.
§ 878.4930 - Suture retention device. Subparts D-E [Reserved]
§ 878.4950 - Manual operating table and accessories Subpart F--General Hospital and Personal Use
and manual operating chair and accessories. Therapeutic Devices
§ 878.4960 - Operating tables and accessories and § 880.5025 - I.V. container.
operating chairs and accessories. § 880.5045 - Medical recirculating air cleaner.
§ 878.5000 - Nonabsorbable poly(ethylene § 880.5075 - Elastic bandage.
terephthalate) surgical suture. § 880.5090 - Liquid bandage.
§ 878.5010 - Nonabsorbable polypropylene surgical § 880.5100 - AC-powered adjustable hospital bed.
suture. § 880.5110 - Hydraulic adjustable hospital bed.
§ 878.5020 - Nonabsorbable polyamide surgical § 880.5120 - Manual adjustable hospital bed.
suture. § 880.5130 - Infant radiant warmer.
§ 878.5030 - Natural nonabsorbable silk surgical § 880.5140 - Pediatric medical crib.
suture. § 880.5145 - Medical bassinet.
§ 878.5035 - Nonabsorbable expanded § 880.5150 - Nonpowered flotation therapy
polytetrafluoroethylene surgical suture. mattress.
§ 878.5040 - Suction lipoplasty system. § 880.5160 - Therapeutic medical binder.
Subpart F--Therapeutic Devices § 880.5180 - Burn sheet.
§ 878.5070 - Air-handling apparatus for a surgical § 880.5200 - Intravascular catheter.
operating room. § 880.5210 - Intravascular catheter securement
§ 878.5350 - Needle-type epilator. device.
§ 878.5360 - Tweezer-type epilator. § 880.5240 - Medical adhesive tape and adhesive
§ 878.5400 - Low level laser system for aesthetic use bandage.
§ 878.5650 - Topical oxygen chamber for § 880.5270 - Neonatal eye pad.
extremities. § 880.5300 - Medical absorbent fiber.
§ 878.5900 - Nonpneumatic tourniquet. § 880.5400 - Neonatal incubator.
§ 878.5910 - Pneumatic tourniquet. § 880.5410 - Neonatal transport incubator.
§ 880.5420 - Pressure infusor for an I.V. bag.
TITLE 21--FOOD AND DRUGS § 880.5430 - Nonelectrically powered fluid injector.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 880.5440 - Intravascular administration set.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 880.5445 - Intravascular administration set,
SUBCHAPTER H--MEDICAL DEVICES automated air removal system.
PART 880 § 880.5450 - Patient care reverse isolation chamber.
GENERAL HOSPITAL AND PERSONAL USE DEVICES § 880.5475 - Jet lavage.
Subpart A--General Provisions § 880.5500 - AC-powered patient lift.
§ 880.1 - Scope. § 880.5510 - Non-AC-powered patient lift.
§ 880.5550 - Alternating pressure air flotation

mattress. § 880.6710 - Medical ultraviolet water purifier.

§ 880.5560 - Temperature regulated water mattress. § 880.6730 - Body waste receptacle.
§ 880.5570 - Hypodermic single lumen needle. § 880.6740 - Vacuum-powered body fluid suction
§ 880.5580 - Acupuncture needle. apparatus.
§ 880.5630 - Nipple shield. § 880.6760 - Protective restraint.
§ 880.5640 - Lamb feeding nipple. § 880.6775 - Powered patient transfer device.
§ 880.5680 - Pediatric position holder. § 880.6785 - Manual patient transfer device.
§ 880.5700 - Neonatal phototherapy unit. § 880.6800 - Washers for body waste receptacles.
§ 880.5725 - Infusion pump. § 880.6820 - Medical disposable scissors.
§ 880.5740 - Suction snakebite kit. § 880.6850 - Sterilization wrap.
§ 880.5760 - Chemical cold pack snakebite kit. § 880.6860 - Ethylene oxide gas sterilizer.
§ 880.5780 - Medical support stocking. § 880.6870 - Dry-heat sterilizer.
§ 880.5820 - Therapeutic scrotal support. § 880.6880 - Steam sterilizer.
§ 880.5860 - Piston syringe. § 880.6885 - Liquid chemical sterilants/high level
§ 880.5950 - Umbilical occlusion device. disinfectants.
§ 880.5960 - Lice removal kit. § 880.6890 - General purpose disinfectants.
§ 880.5965 - Subcutaneous, implanted, intravascular § 880.6900 - Hand-carried stretcher.
infusion port and catheter. § 880.6910 - Wheeled stretcher.
§ 880.5970 - Percutaneous, implanted, long-term § 880.6920 - Syringe needle introducer.
intravascular catheter. § 880.6960 - Irrigating syringe.
Subpart G--General Hospital and Personal Use § 880.6970 - Liquid crystal vein locator.
Miscellaneous Devices § 880.6980 - Vein stabilizer.
§ 880.6025 - Absorbent tipped applicator. § 880.6990 - Infusion stand.
§ 880.6050 - Ice bag. § 880.6991 - Medical washer.
§ 880.6060 - Medical disposable bedding. § 880.6992 - Medical washer-disinfector.
§ 880.6070 - Bed board.
§ 880.6080 - Cardiopulmonary resuscitation board.
§ 880.6085 - Hot/cold water bottle. TITLE 21--FOOD AND DRUGS
§ 880.6100 - Ethylene oxide gas aerator cabinet. CHAPTER I--FOOD AND DRUG ADMINISTRATION
§ 880.6140 - Medical chair and table. DEPARTMENT OF HEALTH AND HUMAN SERVICES
§ 880.6150 - Ultrasonic cleaner for medical SUBCHAPTER H--MEDICAL DEVICES
instruments. PART 864
§ 880.6175 - [Reserved] HEMATOLOGY AND PATHOLOGY DEVICES
§ 880.6185 - Cast cover. Subpart A--General Provisions
§ 880.6190 - Mattress cover for medical purposes. § 864.1 - Scope.
§ 880.6200 - Ring cutter. § 864.3 - Effective dates of requirement for
§ 880.6230 - Tongue depressor. premarket approval.
§ 880.6250 - Non-powdered patient examination § 864.9 - Limitations of exemptions from section
glove. 510(k) of the Federal Food, Drug, and Cosmetic Act
§ 880.6260 - Filtering facepiece respirator for use by (the act).
the general public in public health medical Subpart B--Biological Stains
emergencies. § 864.1850 - Dye and chemical solution stains.
§ 880.6265 - Examination gown. § 864.1860 - Immunohistochemistry reagents and
§ 880.6280 - Medical insole. kits.
§ 880.6300 - Implantable radiofrequency § 864.1870 - Early growth response 1 (EGR1) gene
transponder system for patient identification and fluorescence in-situ hybridization (FISH) test system
health information. for specimen characterization.
§ 880.6305 - Ingestible event marker. Subpart C--Cell And Tissue Culture Products
§ 880.6310 - Medical device data system. § 864.2220 - Synthetic cell and tissue culture media
§ 880.6315 - Remote Medication Management and components.
System. § 864.2240 - Cell and tissue culture supplies and
§ 880.6320 - AC-powered medical examination light. equipment.
§ 880.6350 - Battery-powered medical examination § 864.2260 - Chromosome culture kit.
light. § 864.2280 - Cultured animal and human cells.
§ 880.6375 - Patient lubricant.
§ 864.2360 - Mycoplasma detection media and
§ 880.6430 - Liquid medication dispenser.
components.
§ 880.6450 - Skin pressure protectors.
§ 864.2800 - Animal and human sera.
§ 880.6500 - Medical ultraviolet air purifier.
§ 864.2875 - Balanced salt solutions or formulations.
§ 880.6600 - Ultraviolet (UV) radiation chamber Subpart D--Pathology Instrumentation and
disinfection device. Accessories
 § 864.3010 - Tissue processing equipment. § 864.7360 - Erythrocytic glucose-6-phosphate
§ 864.3250 - Specimen transport and storage dehydrogenase assay.
container. § 864.7375 - Glutathione reductase assay.
§ 864.3260 - OTC test sample collection systems for § 864.7400 - Hemoglobin A[bdi2] assay.
drugs of abuse testing. § 864.7415 - Abnormal hemoglobin assay.
§ 864.3300 - Cytocentrifuge. § 864.7425 - Carboxyhemoglobin assay.
§ 864.3400 - Device for sealing microsections. § 864.7440 - Electrophoretic hemoglobin analysis
§ 864.3600 - Microscopes and accessories. system.
§ 864.3800 - Automated slide stainer. § 864.7455 - Fetal hemoglobin assay.
§ 864.3875 - Automated tissue processor. § 864.7470 - Glycosylated hemoglobin assay.
Subpart E--Specimen Preparation Reagents § 864.7490 - Sulfhemoglobin assay.
§ 864.4010 - General purpose reagent. § 864.7500 - Whole blood hemoglobin assays.
§ 864.4020 - Analyte specific reagents. § 864.7525 - Heparin assay.
§ 864.4400 - Enzyme preparations. § 864.7660 - Leukocyte alkaline phosphatase test.
Subpart F--Automated and Semi-Automated § 864.7675 - Leukocyte peroxidase test.
Hematology Devices § 864.7695 - Platelet factor 4 radioimmunoassay.
§ 864.5200 - Automated cell counter. § 864.7720 - Prothrombin consumption test.
§ 864.5220 - Automated differential cell counter. § 864.7735 - Prothrombin-proconvertin test and
§ 864.5240 - Automated blood cell diluting thrombotest.
apparatus. § 864.7750 - Prothrombin time test.
§ 864.5260 - Automated cell-locating device. § 864.7825 - Sickle cell test.
§ 864.5300 - Red cell indices device. § 864.7875 - Thrombin time test.
§ 864.5350 - Microsedimentation centrifuge. § 864.7900 - Thromboplastin generation test.
§ 864.5400 - Coagulation instrument. § 864.7925 - Partial thromboplastin time tests.
§ 864.5425 - Multipurpose system for in vitro Subpart I--Hematology Reagents
coagulation studies. § 864.8100 - Bothrops atrox reagent.
§ 864.5600 - Automated hematocrit instrument. § 864.8150 - Calibrator for cell indices.
§ 864.5620 - Automated hemoglobin system. § 864.8165 - Calibrator for hemoglobin or hematocrit
§ 864.5680 - Automated heparin analyzer. measurement.
§ 864.5700 - Automated platelet aggregation § 864.8175 - Calibrator for platelet counting.
system. § 864.8185 - Calibrator for red cell and white cell
§ 864.5800 - Automated sedimentation rate device. counting.
§ 864.5850 - Automated slide spinner. § 864.8200 - Blood cell diluent.
§ 864.5950 - Blood volume measuring device. § 864.8500 - Lymphocyte separation medium.
Subpart G--Manual Hematology Devices § 864.8540 - Red cell lysing reagent.
§ 864.6100 - Bleeding time device. § 864.8625 - Hematology quality control mixture.
§ 864.6150 - Capillary blood collection tube. § 864.8950 - Russell viper venom reagent.
§ 864.6160 - Manual blood cell counting device. Subpart J--Products Used In Establishments That
§ 864.6400 - Hematocrit measuring device. Manufacture Blood and Blood Products
§ 864.6550 - Occult blood test. § 864.9050 - Blood bank supplies.
§ 864.6600 - Osmotic fragility test. § 864.9100 - Empty container for the collection and
§ 864.6650 - Platelet adhesion test. processing of blood and blood components.
§ 864.6675 - Platelet aggregometer. § 864.9125 - Vacuum-assisted blood collection
§ 864.6700 - Erythrocyte sedimentation rate test. system.
Subpart H--Hematology Kits and Packages § 864.9145 - Processing system for frozen blood.
§ 864.7040 - Adenosine triphosphate release assay. § 864.9160 - Blood group substances of nonhuman
§ 864.7060 - Antithrombin III assay. origin for in vitro diagnostic use.
§ 864.7100 - Red blood cell enzyme assay. § 864.9175 - Automated blood grouping and
§ 864.7140 - Activated whole blood clotting time antibody test system.
tests. § 864.9185 - Blood grouping view box.
§ 864.7250 - Erythropoietin assay. § 864.9195 - Blood mixing devices and blood
§ 864.7275 - Euglobulin lysis time tests. weighing devices.
§ 864.7280 - Factor V Leiden DNA mutation detection § 864.9205 - Blood and plasma warming device.
systems. § 864.9225 - Cell-freezing apparatus and reagents for
§ 864.7290 - Factor deficiency test. in vitro diagnostic use.
§ 864.7300 - Fibrin monomer paracoagulation test. § 864.9245 - Automated blood cell separator.
§ 864.7320 - Fibrinogen/fibrin degradation products § 864.9275 - Blood bank centrifuge for in vitro
assay. diagnostic use.
§ 864.7340 - Fibrinogen determination system. § 864.9285 - Automated cell-washing centrifuge for
immuno-hematology.

§ 864.9300 - Automated Coombs test systems. § 866.2450 - Supplement for culture media.
§ 864.9320 - Copper sulfate solution for specific § 866.2480 - Quality control kit for culture media.
gravity determinations. § 866.2500 - Microtiter diluting and dispensing
§ 864.9400 - Stabilized enzyme solution. device.
§ 864.9550 - Lectins and protectins. § 866.2540 - Microbiological incubator.
§ 864.9575 - Environmental chamber for storage of § 866.2560 - Microbial growth monitor.
platelet concentrate. § 866.2580 - Gas-generating device.
§ 864.9600 - Potentiating media for in vitro § 866.2600 - Wood's fluorescent lamp.
diagnostic use. § 866.2660 - Microorganism differentiation and
§ 864.9650 - Quality control kit for blood banking identification device.
reagents. § 866.2850 - Automated zone reader.
§ 864.9700 - Blood storage refrigerator and blood § 866.2900 - Microbiological specimen collection and
storage freezer. transport device.
§ 864.9750 - Heat-sealing device. Subpart D--Serological Reagents
§ 864.9875 - Transfer set. § 866.3010 - Acinetobacter calcoaceticus serological
Subpart K--Products Used In Establishments That reagents.
Manufacture Human Cells, Tissues, and Cellular and § 866.3020 - Adenovirus serological reagents.
Tissue-Based Products (HCT/Ps) § 866.3035 - Arizona spp. serological reagents.
§ 864.9900 - Cord blood processing system and § 866.3040 - Aspergillus spp. serological reagents.
storage container. § 866.3050 - Beta-glucan serological assays.
§ 866.3060 - Blastomyces dermatitidis serological
reagents.
TITLE 21--FOOD AND DRUGS § 866.3065 - Bordetella spp. serological reagents.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 866.3085 - Brucella spp. serological reagents.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 866.3110 - Campylobacter fetus serological
SUBCHAPTER H--MEDICAL DEVICES reagents.
PART 866 § 866.3120 - Chlamydia serological reagents.
IMMUNOLOGY AND MICROBIOLOGY DEVICES § 866.3125 - Citrobacter spp. serological reagents.
Subpart A--General Provisions § 866.3130 - Clostridium difficile toxin gene
§ 866.1 - Scope. amplification assay.
§ 866.3 - Effective dates of requirement for § 866.3135 - Coccidioides immitis serological
premarket approval. reagents.
§ 866.9 - Limitations of exemptions from section § 866.3140 - Corynebacterium spp. serological
510(k) of the Federal Food, Drug, and Cosmetic Act reagents.
(the act). § 866.3145 - Coxsackievirus serological reagents.
Subpart B--Diagnostic Devices § 866.3165 - Cryptococcus neoformans serological
§ 866.1620 - Antimicrobial susceptibility test disc. reagents.
§ 866.1640 - Antimicrobial susceptibility test § 866.3175 - Cytomegalovirus serological reagents.
powder. § 866.3200 - Echinococcus spp. serological reagents.
§ 866.1645 - Fully automated short-term incubation § 866.3205 - Echovirus serological reagents.
cycle antimicrobial susceptibility system. § 866.3210 - Endotoxin assay.
§ 866.1700 - Culture medium for antimicrobial § 866.3220 - Entamoeba histolytica serological
susceptibility tests. reagents.
Subpart C--Microbiology Devices § 866.3225 - Enterovirus nucleic acid assay.
§ 866.2050 - Staphylococcal typing bacteriophage. § 866.3235 - Epstein-Barr virus serological reagents.
§ 866.2120 - Anaerobic chamber. § 866.3240 - Equine encephalomyelitis virus
§ 866.2160 - Coagulase plasma. serological reagents.
§ 866.2170 - Automated colony counter. § 866.3250 - Erysipelothrix rhusiopathiae serological
§ 866.2180 - Manual colony counter. reagents.
§ 866.2300 - Multipurpose culture medium. § 866.3255 - Escherichia coli serological reagents.
§ 866.2320 - Differential culture medium. § 866.3270 - Flavobacterium spp. serological
§ 866.2330 - Enriched culture medium. reagents.
§ 866.2350 - Microbiological assay culture medium. § 866.3280 - Francisella tularensis serological
§ 866.2360 - Selective culture medium. reagents.
§ 866.2390 - Transport culture medium. § 866.3290 - Gonococcal antibody test (GAT).
§ 866.3300 - Haemophilus spp. serological reagents.
§ 866.2410 - Culture medium for pathogenic
§ 866.3305 - Herpes simplex virus serological assays.
Neisseria spp.
§ 866.3310 - Hepatitis A virus (HAV) serological
§ 866.2420 - Oxidase screening test for gonorrhea.
assays.
§ 866.2440 - Automated medium dispensing and
§ 866.3320 - Histoplasma capsulatum serological
stacking device.
reagents.
 § 866.3328 - Influenza virus antigen detection test § 866.3820 - Treponema pallidum nontreponemal
system. test reagents.
§ 866.3330 - Influenza virus serological reagents. § 866.3830 - Treponema pallidum treponemal test
§ 866.3332 - Reagents for detection of specific novel reagents.
influenza A viruses. § 866.3850 - Trichinella spiralis serological reagents.
§ 866.3336 - John Cunningham Virus serological § 866.3860 - Trichomonas vaginalis nucleic acid
reagents. assay.
§ 866.3340 - Klebsiella spp. serological reagents. § 866.3870 - Trypanosoma spp. serological reagents.
§ 866.3350 - Leptospira spp. serological reagents. § 866.3900 - Varicella-zoster virus serological
§ 866.3355 - Listeria spp. serological reagents. reagents.
§ 866.3360 - Lymphocytic choriomeningitis virus § 866.3930 - Vibrio cholerae serological reagents.
serological reagents. § 866.3940 - West Nile virus serological reagents.
§ 866.3365 - Multiplex nucleic acid assay for § 866.3945 - Dengue virus serological reagents.
identification of microorganisms and resistance § 866.3946 - Dengue virus nucleic acid amplification
markers from positive blood cultures. test reagents.
§ 866.3370 - Mycobacterium tuberculosis § 866.3950 - In vitro human immunodeficiency virus
immunofluorescent reagents. (HIV) drug resistance genotype assay.
§ 866.3372 - Nucleic acid-based in vitro diagnostic § 866.3980 - Respiratory viral panel multiplex nucleic
devices for the detection of Mycobacterium acid assay.
tuberculosis complex in respiratory specimens. § 866.3990 - Gastrointestinal microorganism
§ 866.3373 - Nucleic acid-based in vitro diagnostic multiplex nucleic acid-based assay.
devices for the detection of Mycobacterium § 866.3215 - Device to detect and measure non-
tuberculosis complex (MTB-complex) and the genetic microbial analyte(s) in human clinical specimens to aid
mutations associated with MTB-complex antibiotic in assessment of patients with suspected sepsis.
resistance in respiratory specimens. Subpart E--Immunology Laboratory Equipment and
§ 866.3375 - Mycoplasma spp. serological reagents. Reagents
§ 866.3380 - Mumps virus serological reagents. § 866.4070 - RNA Preanalytical Systems.
§ 866.3390 - Neisseria spp. direct serological test § 866.4100 - Complement reagent.
reagents. § 866.4500 - Immunoelectrophoresis equipment.
§ 866.3395 - Norovirus serological reagents. § 866.4520 - Immunofluorometer equipment.
§ 866.3400 - Parainfluenza virus serological § 866.4540 - Immunonephelometer equipment.
reagents. § 866.4600 - Ouchterlony agar plate.
§ 866.3402 - Plasmodium species antigen detection § 866.4700 - Automated fluorescence in situ
assays. hybridization (FISH) enumeration systems.
§ 866.3405 - Poliovirus serological reagents. § 866.4800 - Radial immunodiffusion plate.
§ 866.3410 - Proteus spp. (Weil-Felix) serological § 866.4830 - Rocket immunoelectrophoresis
reagents. equipment.
§ 866.3415 - Pseudomonas spp. serological reagents. § 866.4900 - Support gel.
§ 866.3460 - Rabiesvirus immunofluorescent Subpart F--Immunological Test Systems
reagents. § 866.5040 - Albumin immunological test system.
§ 866.3470 - Reovirus serological reagents. § 866.5060 - Prealbumin immunological test system.
§ 866.3480 - Respiratory syncytial virus serological § 866.5065 - Human allotypic marker immunological
reagents. test system.
§ 866.3490 - Rhinovirus serological reagents. § 866.5080 - Alpha-1-antichymotrypsin
§ 866.3500 - Rickettsia serological reagents. immunological test system.
§ 866.3510 - Rubella virus serological reagents. § 866.5090 - Antimitochondrial antibody
§ 866.3520 - Rubeola (measles) virus serological immunological test system.
reagents. § 866.5100 - Antinuclear antibody immunological
§ 866.3550 - Salmonella spp. serological reagents. test system.
§ 866.3600 - Schistosoma spp. serological reagents. § 866.5110 - Antiparietal antibody immunological
§ 866.3630 - Serratia spp. serological reagents. test system.
§ 866.3660 - Shigella spp. serological reagents. § 866.5120 - Antismooth muscle antibody
§ 866.3680 - Sporothrix schenckii serological immunological test system.
reagents. § 866.5130 - Alpha-1-antitrypsin immunological test
§ 866.3700 - Staphylococcus aureus serological system.
reagents. § 866.5150 - Bence-Jones proteins immunological
§ 866.3720 - Streptococcus spp. exoenzyme test system.
reagents. § 866.5160 - Beta-globulin immunological test
§ 866.3740 - Streptococcus spp. serological system.
reagents. § 866.5170 - Breast milk immunological test system.
§ 866.3780 - Toxoplasma gondii serological reagents.

§ 866.5180 - Fecal calprotectin immunological test § 866.5580 - Alpha-1-lipoprotein immunological test

system. system.
§ 866.5200 - Carbonic anhydrase B and C § 866.5590 - Lipoprotein X immunological test
immunological test system. system.
§ 866.5210 - Ceruloplasmin immunological test § 866.5600 - Low-density lipoprotein immunological
system. test system.
§ 866.5220 - Cohn fraction II immunological test § 866.5620 - Alpha-2-macroglobulin immunological
system. test system.
§ 866.5230 - Colostrum immunological test system. § 866.5630 - Beta-2-microglobulin immunological
§ 866.5240 - Complement components test system.
immunological test system. § 866.5640 - Infectious mononucleosis
§ 866.5250 - Complement C[bdi2] inhibitor immunological test system.
(inactivator) immunological test system. § 866.5660 - Multiple autoantibodies immunological
§ 866.5260 - Complement C3b inactivator test system.
immunological test system. § 866.5680 - Myoglobin immunological test system.
§ 866.5270 - C-reactive protein immunological test § 866.5700 - Whole human plasma or serum
system. immunological test system.
§ 866.5320 - Properdin factor B immunological test § 866.5715 - Plasminogen immunological test
system. system.
§ 866.5330 - Factor XIII, A, S, immunological test § 866.5735 - Prothrombin immunological test
system. system.
§ 866.5340 - Ferritin immunological test system. § 866.5750 - Radioallergosorbent (RAST)
§ 866.5350 - Fibrinopeptide A immunological test immunological test system.
system. § 866.5760 - Tryptase test system.
§ 866.5360 - Cohn fraction IV immunological test § 866.5765 - Retinol-binding protein immunological
system. test system.
§ 866.5370 - Cohn fraction V immunological test § 866.5775 - Rheumatoid factor immunological test
system. system.
§ 866.5380 - Free secretory component § 866.5785 - Anti-Saccharomyces cerevisiae (S.
immunological test system. cerevisiae) antibody (ASCA) test systems.
§ 866.5400 - Alpha-globulin immunological test § 866.5800 - Seminal fluid (sperm) immunological
system. test system.
§ 866.5420 - Alpha-1-glycoproteins immunological § 866.5820 - Systemic lupus erythematosus
test system. immunological test system.
§ 866.5425 - Alpha-2-glycoproteins immunological § 866.5860 - Total spinal fluid immunological test
test system. system.
§ 866.5430 - Beta-2-glycoprotein I immunological § 866.5870 - Thyroid autoantibody immunological
test system. test system.
§ 866.5440 - Beta-2-glycoprotein III immunological § 866.5880 - Transferrin immunological test system.
test system. § 866.5890 - Inter-alpha trypsin inhibitor
§ 866.5460 - Haptoglobin immunological test immunological test system.
system. § 866.5900 - Cystic fibrosis transmembrane
§ 866.5470 - Hemoglobin immunological test conductance regulator (CFTR) gene mutation detection
system. system.
§ 866.5490 - Hemopexin immunological test system. § 866.5910 - Quality control material for cystic
§ 866.5500 - Hypersensitivity pneumonitis fibrosis nucleic acid assays.
immunological test system. § 866.5940 - Autosomal recessive carrier screening
§ 866.5510 - Immunoglobulins A, G, M, D, and E gene mutation detection system.
immunological test system. Subpart G--Tumor Associated Antigen immunological
§ 866.5520 - Immunoglobulin G (Fab fragment Test Systems
specific) immunological test system. § 866.6010 - Tumor-associated antigen
§ 866.5530 - Immunoglobulin G (Fc fragment immunological test system.
specific) immunological test system. § 866.6020 - Immunomagnetic circulating cancer cell
§ 866.5540 - Immunoglobulin G (Fd fragment selection and enumeration system.
specific) immunological test system. § 866.6030 - AFP-L3% immunological test system.
§ 866.5550 - Immunoglobulin (light chain specific) § 866.6040 - Gene expression profiling test system
immunological test system. for breast cancer prognosis.
§ 866.5560 - Lactic dehydrogenase immunological § 866.6050 - Ovarian adnexal mass assessment score
test system. test system.
§ 866.5570 - Lactoferrin immunological test system.
 § 866.6080 - Next generation sequencing based § 882.1790 - Ocular plethysmograph.
tumor profiling test. § 882.1825 - Rheoencephalograph.
§ 882.1835 - Physiological signal amplifier.
§ 882.1845 - Physiological signal conditioner.
TITLE 21--FOOD AND DRUGS § 882.1855 - Electroencephalogram (EEG) telemetry
CHAPTER I--FOOD AND DRUG ADMINISTRATION system.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 882.1870 - Evoked response electrical stimulator.
SUBCHAPTER H--MEDICAL DEVICES § 882.1880 - Evoked response mechanical
PART 882 stimulator.
NEUROLOGICAL DEVICES § 882.1890 - Evoked response photic stimulator.
Subpart A--General Provisions § 882.1900 - Evoked response auditory stimulator.
§ 882.1 - Scope. § 882.1925 - Ultrasonic scanner calibration test
§ 882.3 - Effective dates of requirement for block.
premarket approval. § 882.1935 - Near Infrared (NIR) Brain Hematoma
§ 882.9 - Limitations of exemptions from section Detector.
510(k) of the Federal Food, Drug, and Cosmetic Act § 882.1950 - Tremor transducer.
(the act). Subparts C-D [Reserved]
Subpart B--Neurological Diagnostic Devices Subpart E--Neurological Surgical Devices
§ 882.1020 - Rigidity analyzer. § 882.4030 - Skull plate anvil.
§ 882.1030 - Ataxiagraph. § 882.4060 - Ventricular cannula.
§ 882.1200 - Two-point discriminator. § 882.4100 - Ventricular catheter.
§ 882.1240 - Echoencephalograph. § 882.4125 - Neurosurgical chair.
§ 882.1275 - Electroconductive media. § 882.4150 - Scalp clip.
§ 882.1310 - Cortical electrode. § 882.4175 - Aneurysm clip applier.
§ 882.1320 - Cutaneous electrode. § 882.4190 - Clip forming/cutting instrument.
§ 882.1330 - Depth electrode. § 882.4200 - Clip removal instrument.
§ 882.1340 - Nasopharyngeal electrode. § 882.4215 - Clip rack.
§ 882.1350 - Needle electrode. § 882.4250 - Cryogenic surgical device.
§ 882.1400 - Electroencephalograph. § 882.4275 - Dowel cutting instrument.
§ 882.1410 - Electroencephalograph electrode/lead § 882.4300 - Manual cranial drills, burrs, trephines,
tester. and their accessories
§ 882.1420 - Electroencephalogram (EEG) signal § 882.4305 - Powered compound cranial drills, burrs,
spectrum analyzer. trephines, and their accessories.
§ 882.1430 - Electroencephalograph test signal § 882.4310 - Powered simple cranial drills, burrs,
generator. trephines, and their accessories.
§ 882.1440 - Neuropsychiatric interpretive § 882.4325 - Cranial drill handpiece (brace).
electroencephalograph assessment aid. § 882.4360 - Electric cranial drill motor.
§ 882.1450 - Brain injury adjunctive interpretive § 882.4370 - Pneumatic cranial drill motor.
electroencephalograph assessment aid. § 882.4400 - Radiofrequency lesion generator.
§ 882.1460 - Nystagmograph. § 882.4440 - Neurosurgical headrests.
§ 882.1470 - Computerized cognitive assessment § 882.4460 - Neurosurgical head holder (skull
aid. clamp).
§ 882.1471 - Computerized cognitive assessment aid § 882.4500 - Cranioplasty material forming
for concussion. instrument.
§ 882.1480 - Neurological endoscope. § 882.4525 - Microsurgical instrument.
§ 882.1500 - Esthesiometer. § 882.4535 - Nonpowered neurosurgical instrument.
§ 882.1525 - Tuning fork. § 882.4545 - Shunt system implantation instrument.
§ 882.1540 - Galvanic skin response measurement § 882.4560 - Stereotaxic instrument.
device. § 882.4600 - Leukotome.
§ 882.1550 - Nerve conduction velocity § 882.4650 - Neurosurgical suture needle.
measurement device. § 882.4700 - Neurosurgical paddie.
§ 882.1560 - Skin potential measurement device. § 882.4725 - Radiofrequency lesion probe.
§ 882.1561 - Evoked photon image capture device. § 882.4750 - Skull punch.
§ 882.1570 - Powered direct-contact temperature § 882.4800 - Self-retaining retractor for
measurement device. neurosurgery.
§ 882.1610 - Alpha monitor. § 882.4840 - Manual rongeur.
§ 882.1620 - Intracranial pressure monitoring § 882.4845 - Powered rongeur.
device. § 882.4900 - Skullplate screwdriver.
§ 882.1700 - Percussor. Subpart F--Neurological Therapeutic Devices
§ 882.1750 - Pinwheel. § 882.5030 - Methyl methacrylate for

aneurysmorrhaphy. DEPARTMENT OF HEALTH AND HUMAN SERVICES

§ 882.5050 - Biofeedback device. SUBCHAPTER H--MEDICAL DEVICES
§ 882.5070 - Bite block. PART 884
§ 882.5150 - Intravascular occluding catheter. OBSTETRICAL AND GYNECOLOGICAL DEVICES
§ 882.5175 - Carotid artery clamp. Subpart A--General Provisions
§ 882.5200 - Aneurysm clip. § 884.1 - Scope.
§ 882.5225 - Implanted malleable clip. § 884.3 - Effective dates of requirement for
§ 882.5235 - Aversive conditioning device. premarket approval.
§ 882.5250 - Burr hole cover. § 884.9 - Limitations of exemptions from section
§ 882.5275 - Nerve cuff. 510(k) of the Federal Food, Drug, and Cosmetic Act
§ 882.5300 - Methyl methacrylate for cranioplasty. (the act).
§ 882.5320 - Preformed alterable cranioplasty plate. Subpart B--Obstetrical and Gynecological Diagnostic
§ 882.5330 - Preformed nonalterable cranioplasty Devices
plate. § 884.1040 - Viscometer for cervical mucus.
§ 882.5360 - Cranioplasty plate fastener. § 884.1050 - Endocervical aspirator.
§ 882.5500 - Lesion temperature monitor. § 884.1060 - Endometrial aspirator.
§ 882.5550 - Central nervous system fluid shunt and § 884.1100 - Endometrial brush.
components. § 884.1175 - Endometrial suction curette and
§ 882.5600 - Neurovascular mechanical accessories.
thrombectomy device for acute ischemic stroke § 884.1185 - Endometrial washer.
treatment. § 884.1300 - Uterotubal carbon dioxide insufflator
§ 882.5700 - Thermal system for insomnia. and accessories.
§ 882.5800 - Cranial electrotherapy stimulator. § 884.1425 - Perineometer.
§ 882.5805 - Repetitive transcranial magnetic § 884.1550 - Amniotic fluid sampler (amniocentesis
stimulation system. tray).
§ 882.5808 - Transcranial magnetic stimulator for § 884.1560 - Fetal blood sampler.
headache. § 884.1600 - Transabdominal amnioscope
§ 882.5810 - External functional neuromuscular (fetoscope) and accessories.
stimulator. § 884.1630 - Colposcope.
§ 882.5820 - Implanted cerebellar stimulator. § 884.1640 - Culdoscope and accessories.
§ 882.5830 - Implanted diaphragmatic/phrenic nerve § 884.1660 - Transcervical endoscope (amnioscope)
stimulator. and accessories.
§ 882.5840 - Implanted intracerebral/subcortical § 884.1690 - Hysteroscope and accessories.
stimulator for pain relief. § 884.1700 - Hysteroscopic insufflator.
§ 882.5850 - Implanted spinal cord stimulator for § 884.1720 - Gynecologic laparoscope and
bladder evacuation. accessories.
§ 882.5860 - Implanted neuromuscular stimulator. § 884.1730 - Laparoscopic insufflator.
§ 882.5870 - Implanted peripheral nerve stimulator Subpart C--Obstetrical and Gynecological Monitoring
for pain relief. Devices
§ 882.5880 - Implanted spinal cord stimulator for § 884.2050 - Obstetric data analyzer.
pain relief. § 884.2225 - Obstetric-gynecologic ultrasonic
§ 882.5890 - Transcutaneous electrical nerve imager.
stimulator for pain relief. § 884.2600 - Fetal cardiac monitor.
§ 882.5891 - Transcutaneous electrical nerve § 884.2620 - Fetal electroencephalographic monitor.
stimulator to treat headache. § 884.2640 - Fetal phonocardiographic monitor and
§ 882.5894 - Limited output transcutaneous accessories.
piezoelectric stimulator for skin reactions associated § 884.2660 - Fetal ultrasonic monitor and
with insect bites. accessories.
§ 882.5895 - Vibratory counter-stimulation device. § 884.2675 - Fetal scalp circular (spiral) electrode and
§ 882.5900 - Preformed craniosynostosis strip. applicator.
§ 882.5910 - Dura substitute. § 884.2685 - Fetal scalp clip electrode and
§ 882.5940 - Electroconvulsive therapy device. applicator.
§ 882.5950 - Neurovascular embolization device. § 884.2700 - Intrauterine pressure monitor and
§ 882.5960 - Skull tongs for traction. accessories.
§ 882.5970 - Cranial orthosis. § 884.2720 - External uterine contraction monitor
§ 882.5975 - Human dura mater. and accessories.
§ 884.2730 - Home uterine activity monitor.
§ 884.2740 - Perinatal monitoring system and
TITLE 21--FOOD AND DRUGS accessories.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 884.2800 - Computerized Labor Monitoring
System.
 § 884.2900 - Fetal stethoscope. § 884.5400 - Menstrual cup.
§ 884.2960 - Obstetric ultrasonic transducer and § 884.5425 - Scented or scented deodorized
accessories. menstrual pad.
§ 884.2980 - Telethermographic system. § 884.5435 - Unscented menstrual pad.
§ 884.2982 - Liquid crystal thermographic system. § 884.5460 - Scented or scented deodorized
§ 884.2990 - Breast lesion documentation system. menstrual tampon.
Subpart D--Obstetrical and Gynecological Prosthetic § 884.5470 - Unscented menstrual tampon.
Devices § 884.5900 - Therapeutic vaginal douche apparatus.
§ 884.3200 - Cervical drain. § 884.5920 - Vaginal insufflator.
§ 884.3575 - Vaginal pessary. § 884.5940 - Powered vaginal muscle stimulator for
§ 884.3650 - Fallopian tube prosthesis. therapeutic use.
§ 884.3900 - Vaginal stent. § 884.5960 - Genital vibrator for therapeutic use.
Subpart E--Obstetrical and Gynecological Surgical § 884.5970 - Clitoral engorgement device.
Devices § 884.5980 - Surgical mesh for transvaginal pelvic
§ 884.4050 - Gynecologic laparoscopic power organ prolapse repair.
morcellation containment system. Subpart G--Assisted Reproduction Devices
§ 884.4100 - Endoscopic electrocautery and § 884.6100 - Assisted reproduction needles.
accessories. § 884.6110 - Assisted reproduction catheters.
§ 884.4120 - Gynecologic electrocautery and § 884.6120 - Assisted reproduction accessories.
accessories. § 884.6130 - Assisted reproduction microtools.
§ 884.4150 - Bipolar endoscopic coagulator-cutter § 884.6140 - Assisted reproduction micropipette
and accessories. fabrication instruments.
§ 884.4160 - Unipolar endoscopic coagulator-cutter § 884.6150 - Assisted reproduction
and accessories. micromanipulators and microinjectors.
§ 884.4250 - Expandable cervical dilator. § 884.6160 - Assisted reproduction labware.
§ 884.4260 - Hygroscopic Laminaria cervical dilator. § 884.6165 - Intravaginal culture system.
§ 884.4270 - Vibratory cervical dilators. § 884.6170 - Assisted reproduction water and water
§ 884.4340 - Fetal vacuum extractor. purification systems.
§ 884.4400 - Obstetric forceps. § 884.6180 - Reproductive media and supplements.
§ 884.4500 - Obstetric fetal destructive instrument. § 884.6190 - Assisted reproductive microscopes and
§ 884.4520 - Obstetric-gynecologic general manual microscope accessories.
instrument. § 884.6195 - Assisted Reproduction Embryo Image
§ 884.4530 - Obstetric-gynecologic specialized Assessment System.
manual instrument. § 884.6200 - Assisted reproduction laser system.
§ 884.4550 - Gynecologic surgical laser.
§ 884.4900 - Obstetric table and accessories.
§ 884.4910 - Specialized surgical instrumentation for TITLE 21--FOOD AND DRUGS
use with urogynecologic surgical mesh. CHAPTER I--FOOD AND DRUG ADMINISTRATION
Subpart F--Obstetrical and Gynecological Therapeutic DEPARTMENT OF HEALTH AND HUMAN SERVICES
Devices SUBCHAPTER H--MEDICAL DEVICES
§ 884.5050 - Metreurynter-balloon abortion system. PART 886
§ 884.5070 - Vacuum abortion system. OPHTHALMIC DEVICES
§ 884.5100 - Obstetric anesthesia set. Subpart A--General Provisions
§ 884.5150 - Nonpowered breast pump. § 886.1 - Scope.
§ 884.5160 - Powered breast pump. § 886.3 - Effective dates of requirement for
§ 884.5200 - Hemorrhoid prevention pressure premarket approval.
wedge. § 886.9 - Limitations of exemptions from section
§ 884.5225 - Abdominal decompression chamber. 510(k) of the Federal Food, Drug, and Cosmetic Act
§ 884.5250 - Cervical cap. (the act).
§ 884.5300 - Condom. Subpart B--Diagnostic Devices
§ 884.5310 - Condom with spermicidal lubricant. § 886.1270 - Exophthalmometer.
§ 884.5320 - Glans sheath. § 886.1290 - Fixation device.
§ 884.5330 - Female condom. § 886.1300 - Afterimage flasher.
§ 884.5350 - Contraceptive diaphragm and § 886.1320 - Fornixscope.
accessories. § 886.1330 - Amsler grid.
§ 884.5360 - Contraceptive intrauterine device (IUD) § 886.1340 - Haploscope.
and introducer. § 886.1342 - Strabismus detection device.
§ 884.5380 - Contraceptive tubal occlusion device § 886.1350 - Keratoscope.
(TOD) and introducer. § 886.1360 - Visual field laser instrument.
§ 884.5390 - Perineal heater. § 886.1375 - Bagolini lens.

§ 886.1380 - Diagnostic condensing lens. § 886.1250 - Euthyscope.

§ 886.1385 - Polymethylmethacrylate (PMMA) Subpart C [Reserved]
diagnostic contact lens. Subpart D--Prosthetic Devices
§ 886.1390 - Flexible diagnostic Fresnel lens. § 886.3100 - Ophthalmic tantalum clip.
§ 886.1395 - Diagnostic Hruby fundus lens. § 886.3130 - Ophthalmic conformer.
§ 886.1400 - Maddox lens. § 886.3200 - Artificial eye.
§ 886.1405 - Ophthalmic trial lens set. § 886.3300 - Absorbable implant (scleral buckling
§ 886.1410 - Ophthalmic trial lens clip. method).
§ 886.1415 - Ophthalmic trial lens frame. § 886.3320 - Eye sphere implant.
§ 886.1420 - Ophthalmic lens gauge. § 886.3340 - Extraocular orbital implant.
§ 886.1425 - Lens measuring instrument. § 886.3400 - Keratoprosthesis.
§ 886.1430 - Ophthalmic contact lens radius § 886.3600 - Intraocular lens.
measuring device. § 886.3800 - Scleral shell.
§ 886.1435 - Maxwell spot. § 886.3920 - Aqueous shunt.
§ 886.1450 - Corneal radius measuring device. Subpart E--Surgical Devices
§ 886.1460 - Stereopsis measuring instrument. § 886.4070 - Powered corneal burr.
§ 886.1500 - Headband mirror. § 886.4100 - Radiofrequency electrosurgical cautery
§ 886.1510 - Eye movement monitor. apparatus.
§ 886.1570 - Ophthalmoscope. § 886.4115 - Thermal cautery unit.
§ 886.1605 - Perimeter. § 886.4150 - Vitreous aspiration and cutting
§ 886.1630 - AC-powered photostimulator. instrument.
§ 886.1640 - Ophthalmic preamplifier. § 886.4155 - Scleral plug.
§ 886.1650 - Ophthalmic bar prism. § 886.4170 - Cryophthalmic unit.
§ 886.1655 - Ophthalmic Fresnel prism. § 886.4230 - Ophthalmic knife test drum.
§ 886.1660 - Gonioscopic prism. § 886.4250 - Ophthalmic electrolysis unit.
§ 886.1665 - Ophthalmic rotary prism. § 886.4270 - Intraocular gas.
§ 886.1670 - Ophthalmic isotope uptake probe. § 886.4275 - Intraocular fluid.
§ 886.1680 - Ophthalmic projector. § 886.4280 - Intraocular pressure measuring device.
§ 886.1690 - Pupillograph. § 886.4300 - Intraocular lens guide.
§ 886.1700 - Pupillometer. § 886.4335 - Operating headlamp.
§ 886.1750 - Skiascopic rack. § 886.4350 - Manual ophthalmic surgical instrument.
§ 886.1760 - Ophthalmic refractometer. § 886.4360 - Ocular surgery irrigation device.
§ 886.1770 - Manual refractor. § 886.4370 - Keratome.
§ 886.1780 - Retinoscope. § 886.4390 - Ophthalmic laser.
§ 886.1790 - Nearpoint ruler. § 886.4392 - Nd:YAG laser for posterior capsulotomy
§ 886.1800 - Schirmer strip. and peripheral iridotomy.
§ 886.1810 - Tangent screen (campimeter). § 886.4400 - Electronic metal locator.
§ 886.1840 - Simulatan (including crossed cylinder). § 886.4440 - AC-powered magnet.
§ 886.1850 - AC-powered slitlamp biomicroscope. § 886.4445 - Permanent magnet.
§ 886.1860 - Ophthalmic instrument stand. § 886.4570 - Ophthalmic surgical marker.
§ 886.1870 - Stereoscope. § 886.4610 - Ocular pressure applicator.
§ 886.1880 - Fusion and stereoscopic target. § 886.4670 - Phacofragmentation system.
§ 886.1905 - Nystagmus tape. § 886.4690 - Ophthalmic photocoagulator.
§ 886.1910 - Spectacle dissociation test system. § 886.4750 - Ophthalmic eye shield.
§ 886.1925 - Diurnal pattern recorder system. § 886.4770 - Ophthalmic operating spectacles
§ 886.1930 - Tonometer and accessories. (loupes).
§ 886.1940 - Tonometer sterilizer. § 886.4790 - Ophthalmic sponge.
§ 886.1945 - Transilluminator. § 886.4855 - Ophthalmic instrument table.
§ 886.1040 - Ocular esthesiometer. Subpart F--Therapeutic Devices
§ 886.1050 - Adaptometer (biophotometer). § 886.5100 - Ophthalmic beta radiation source.
§ 886.1070 - Anomaloscope. § 886.5120 - Low-power binocular loupe.
§ 886.1090 - Haidinger brush. § 886.5200 - Eyelid thermal pulsation system.
§ 886.1120 - Ophthalmic camera. § 886.5420 - Contact lens inserter/remover.
§ 886.1140 - Ophthalmic chair. § 886.5540 - Low-vision magnifier.
§ 886.1150 - Visual acuity chart. § 886.5600 - Ptosis crutch.
§ 886.1160 - Color vision plate illuminator. § 886.5700 - Eyelid weight.
§ 886.1170 - Color vision tester. § 886.5800 - Ophthalmic bar reader.
§ 886.1190 - Distometer. § 886.5810 - Ophthalmic prism reader.
§ 886.1200 - Optokinetic drum. § 886.5820 - Closed-circuit television reading
§ 886.1220 - Corneal electrode. system.
 § 886.5838 - Nasolacrimal compression device. § 888.3080 - Intervertebral body fusion device.
§ 886.5840 - Magnifying spectacles. § 888.3100 - Ankle joint metal/composite semi-
§ 886.5842 - Spectacle frame. constrained cemented prosthesis.
§ 886.5844 - Prescription spectacle lens. § 888.3110 - Ankle joint metal/polymer semi-
§ 886.5850 - Sunglasses (nonprescription). constrained cemented prosthesis.
§ 886.5870 - Low-vision telescope. § 888.3120 - Ankle joint metal/polymer non-
§ 886.5900 - Electronic vision aid. constrained cemented prosthesis.
§ 886.5905 - Oral electronic vision aid. § 888.3150 - Elbow joint metal/polymer constrained
§ 886.5910 - Image intensification vision aid. cemented prosthesis.
§ 886.5915 - Optical vision aid. § 888.3160 - Elbow joint metal/polymer semi-
§ 886.5916 - Rigid gas permeable contact lens. constrained cemented prosthesis.
§ 886.5918 - Rigid gas permeable contact lens care § 888.3170 - Elbow joint radial (hemi-elbow) polymer
products. prosthesis.
§ 886.5925 - Soft (hydrophilic) contact lens. § 888.3180 - Elbow joint humeral (hemi-elbow)
§ 886.5928 - Soft (hydrophilic) contact lens care metallic uncemented prosthesis.
products. § 888.3200 - Finger joint metal/metal constrained
§ 886.5933 - [Reserved] uncemented prosthesis.
§ 888.3210 - Finger joint metal/metal constrained
cemented prosthesis.
TITLE 21--FOOD AND DRUGS § 888.3220 - Finger joint metal/polymer constrained
CHAPTER I--FOOD AND DRUG ADMINISTRATION cemented prosthesis.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 888.3230 - Finger joint polymer constrained
SUBCHAPTER H--MEDICAL DEVICES prosthesis.
PART 888 § 888.3300 - Hip joint metal constrained cemented
ORTHOPEDIC DEVICES or uncemented prosthesis.
Subpart A--General Provisions § 888.3310 - Hip joint metal/polymer constrained
§ 888.1 - Scope. cemented or uncemented prosthesis.
§ 888.3 - Effective dates of requirement for § 888.3320 - Hip joint metal/metal semi-constrained,
premarket approval. with a cemented acetabular component, prosthesis.
§ 888.5 - Resurfacing technique. § 888.3330 - Hip joint metal/metal semi-constrained,
§ 888.6 - Degree of constraint. with an uncemented acetabular component,
§ 888.9 - Limitations of exemptions from section prosthesis.
510(k) of the Federal Food, Drug, and Cosmetic Act § 888.3340 - Hip joint metal/composite semi-
(the act). constrained cemented prosthesis.
Subpart B--Diagnostic Devices § 888.3350 - Hip joint metal/polymer semi-
§ 888.1100 - Arthroscope. constrained cemented prosthesis.
§ 888.1240 - AC-powered dynamometer. § 888.3353 - Hip joint metal/ceramic/polymer semi-
§ 888.1250 - Nonpowered dynamometer. constrained cemented or nonporous uncemented
§ 888.1500 - Goniometer. prosthesis.
§ 888.1520 - Nonpowered goniometer. § 888.3358 - Hip joint metal/polymer/metal semi-
Subpart C [Reserved] constrained porous-coated uncemented prosthesis.
Subpart D--Prosthetic Devices § 888.3360 - Hip joint femoral (hemi-hip) metallic
§ 888.3000 - Bone cap. cemented or uncemented prosthesis.
§ 888.3010 - Bone fixation cerclage. § 888.3370 - Hip joint (hemi-hip) acetabular metal
§ 888.3015 - Bone heterograft. cemented prosthesis.
§ 888.3020 - Intramedullary fixation rod. § 888.3380 - Hip joint femoral (hemi-hip) trunnion-
§ 888.3025 - Passive tendon prosthesis. bearing metal/polyacetal cemented prosthesis.
§ 888.3027 - Polymethylmethacrylate (PMMA) bone § 888.3390 - Hip joint femoral (hemi-hip)
cement. metal/polymer cemented or uncemented prosthesis.
§ 888.3030 - Single/multiple component metallic § 888.3400 - Hip joint femoral (hemi-hip) metallic
bone fixation appliances and accessories. resurfacing prosthesis.
§ 888.3040 - Smooth or threaded metallic bone § 888.3410 - Hip joint metal/polymer or
fixation fastener. ceramic/polymer semiconstrained resurfacing
§ 888.3045 - Resorbable calcium salt bone void filler cemented prosthesis.
device. § 888.3480 - Knee joint femorotibial metallic
§ 888.3050 - Spinal interlaminal fixation orthosis. constrained cemented prosthesis.
§ 888.3060 - Spinal intervertebral body fixation § 888.3490 - Knee joint femorotibial
orthosis. metal/composite non-constrained cemented
§ 888.3070 - Thoracolumbosacral pedicle screw prosthesis.
system.

§ 888.3500 - Knee joint femorotibial Subpart E--Surgical Devices

metal/composite semi-constrained cemented § 888.4150 - Calipers for clinical use.
prosthesis. § 888.4200 - Cement dispenser.
§ 888.3510 - Knee joint femorotibial metal/polymer § 888.4210 - Cement mixer for clinical use.
constrained cemented prosthesis. § 888.4220 - Cement monomer vapor evacuator.
§ 888.3520 - Knee joint femorotibial metal/polymer § 888.4230 - Cement ventilation tube.
non-constrained cemented prosthesis. § 888.4300 - Depth gauge for clinical use.
§ 888.3530 - Knee joint femorotibial metal/polymer § 888.4540 - Orthopedic manual surgical instrument.
semi-constrained cemented prosthesis. § 888.4580 - Sonic surgical instrument and
§ 888.3535 - Knee joint femorotibial (uni- accessories/attachments.
compartmental) metal/polymer porous-coated § 888.4600 - Protractor for clinical use.
uncemented prosthesis. § 888.4800 - Template for clinical use.
§ 888.3540 - Knee joint patellofemoral § 888.5850 - Nonpowered orthopedic traction
polymer/metal semi-constrained cemented apparatus and accessories.
prosthesis.
§ 888.5890 - Noninvasive traction component.
§ 888.3550 - Knee joint patellofemorotibial
§ 888.5940 - Cast component.
polymer/metal/metal constrained cemented
§ 888.5960 - Cast removal instrument.
prosthesis.
§ 888.5980 - Manual cast application and removal
§ 888.3560 - Knee joint patellofemorotibial
instrument
polymer/metal/polymer semi-constrained cemented
prosthesis.
§ 888.3565 - Knee joint patellofemorotibial
TITLE 21--FOOD AND DRUGS
metal/polymer porous-coated uncemented
prosthesis. CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
§ 888.3570 - Knee joint femoral (hemi-knee) metallic
uncemented prosthesis. SUBCHAPTER H--MEDICAL DEVICES
PART 864
§ 888.3580 - Knee joint patellar (hemi-knee) metallic
HEMATOLOGY AND PATHOLOGY DEVICES
resurfacing uncemented prosthesis.
Subpart A--General Provisions
§ 888.3590 - Knee joint tibial (hemi-knee) metallic
resurfacing uncemented prosthesis. § 864.1 - Scope.
§ 888.3640 - Shoulder joint metal/metal or § 864.3 - Effective dates of requirement for
metal/polymer constrained cemented prosthesis. premarket approval.
§ 864.9 - Limitations of exemptions from section
§ 888.3650 - Shoulder joint metal/polymer non-
510(k) of the Federal Food, Drug, and Cosmetic Act
constrained cemented prosthesis.
(the act).
§ 888.3660 - Shoulder joint metal/polymer semi-
Subpart B--Biological Stains
constrained cemented prosthesis.
§ 864.1850 - Dye and chemical solution stains.
§ 888.3670 - Shoulder joint metal/polymer/metal § 864.1860 - Immunohistochemistry reagents and
nonconstrained or semi-constrained porous-coated kits.
uncemented prosthesis.
§ 864.1870 - Early growth response 1 (EGR1) gene
§ 888.3680 - Shoulder joint glenoid (hemi-shoulder)
fluorescence in-situ hybridization (FISH) test system
metallic cemented prosthesis.
for specimen characterization.
§ 888.3690 - Shoulder joint humeral (hemi-shoulder)
Subpart C--Cell And Tissue Culture Products
metallic uncemented prosthesis.
§ 864.2220 - Synthetic cell and tissue culture media
§ 888.3720 - Toe joint polymer constrained
and components.
prosthesis.
§ 864.2240 - Cell and tissue culture supplies and
§ 888.3730 - Toe joint phalangeal (hemi-toe) polymer
equipment.
prosthesis.
§ 864.2260 - Chromosome culture kit.
§ 888.3750 - Wrist joint carpal lunate polymer
§ 864.2280 - Cultured animal and human cells.
prosthesis.
§ 864.2360 - Mycoplasma detection media and
§ 888.3760 - Wrist joint carpal scaphoid polymer
components.
prosthesis.
§ 864.2800 - Animal and human sera.
§ 888.3770 - Wrist joint carpal trapezium polymer
§ 864.2875 - Balanced salt solutions or formulations.
prosthesis.
Subpart D--Pathology Instrumentation and
§ 888.3780 - Wrist joint polymer constrained
Accessories
prosthesis.
§ 864.3010 - Tissue processing equipment.
§ 888.3790 - Wrist joint metal constrained cemented
§ 864.3250 - Specimen transport and storage
prosthesis.
container.
§ 888.3800 - Wrist joint metal/polymer semi-
§ 864.3260 - OTC test sample collection systems for
constrained cemented prosthesis.
drugs of abuse testing.
§ 888.3810 - Wrist joint ulnar (hemi-wrist) polymer
§ 864.3300 - Cytocentrifuge.
prosthesis.
 § 864.3400 - Device for sealing microsections. system.
§ 864.3600 - Microscopes and accessories. § 864.7455 - Fetal hemoglobin assay.
§ 864.3800 - Automated slide stainer. § 864.7470 - Glycosylated hemoglobin assay.
§ 864.3875 - Automated tissue processor. § 864.7490 - Sulfhemoglobin assay.
Subpart E--Specimen Preparation Reagents § 864.7500 - Whole blood hemoglobin assays.
§ 864.4010 - General purpose reagent. § 864.7525 - Heparin assay.
§ 864.4020 - Analyte specific reagents. § 864.7660 - Leukocyte alkaline phosphatase test.
§ 864.4400 - Enzyme preparations. § 864.7675 - Leukocyte peroxidase test.
Subpart F--Automated and Semi-Automated § 864.7695 - Platelet factor 4 radioimmunoassay.
Hematology Devices § 864.7720 - Prothrombin consumption test.
§ 864.5200 - Automated cell counter. § 864.7735 - Prothrombin-proconvertin test and
§ 864.5220 - Automated differential cell counter. thrombotest.
§ 864.5240 - Automated blood cell diluting § 864.7750 - Prothrombin time test.
apparatus. § 864.7825 - Sickle cell test.
§ 864.5260 - Automated cell-locating device. § 864.7875 - Thrombin time test.
§ 864.5300 - Red cell indices device. § 864.7900 - Thromboplastin generation test.
§ 864.5350 - Microsedimentation centrifuge. § 864.7925 - Partial thromboplastin time tests.
§ 864.5400 - Coagulation instrument. Subpart I--Hematology Reagents
§ 864.5425 - Multipurpose system for in vitro § 864.8100 - Bothrops atrox reagent.
coagulation studies. § 864.8150 - Calibrator for cell indices.
§ 864.5600 - Automated hematocrit instrument. § 864.8165 - Calibrator for hemoglobin or hematocrit
§ 864.5620 - Automated hemoglobin system. measurement.
§ 864.5680 - Automated heparin analyzer. § 864.8175 - Calibrator for platelet counting.
§ 864.5700 - Automated platelet aggregation § 864.8185 - Calibrator for red cell and white cell
system. counting.
§ 864.5800 - Automated sedimentation rate device. § 864.8200 - Blood cell diluent.
§ 864.5850 - Automated slide spinner. § 864.8500 - Lymphocyte separation medium.
§ 864.5950 - Blood volume measuring device. § 864.8540 - Red cell lysing reagent.
Subpart G--Manual Hematology Devices § 864.8625 - Hematology quality control mixture.
§ 864.6100 - Bleeding time device. § 864.8950 - Russell viper venom reagent.
§ 864.6150 - Capillary blood collection tube. Subpart J--Products Used In Establishments That
§ 864.6160 - Manual blood cell counting device. Manufacture Blood and Blood Products
§ 864.6400 - Hematocrit measuring device. § 864.9050 - Blood bank supplies.
§ 864.6550 - Occult blood test. § 864.9100 - Empty container for the collection and
§ 864.6600 - Osmotic fragility test. processing of blood and blood components.
§ 864.6650 - Platelet adhesion test. § 864.9125 - Vacuum-assisted blood collection
§ 864.6675 - Platelet aggregometer. system.
§ 864.6700 - Erythrocyte sedimentation rate test. § 864.9145 - Processing system for frozen blood.
Subpart H--Hematology Kits and Packages § 864.9160 - Blood group substances of nonhuman
§ 864.7040 - Adenosine triphosphate release assay. origin for in vitro diagnostic use.
§ 864.7060 - Antithrombin III assay. § 864.9175 - Automated blood grouping and
§ 864.7100 - Red blood cell enzyme assay. antibody test system.
§ 864.7140 - Activated whole blood clotting time § 864.9185 - Blood grouping view box.
tests. § 864.9195 - Blood mixing devices and blood
§ 864.7250 - Erythropoietin assay. weighing devices.
§ 864.7275 - Euglobulin lysis time tests. § 864.9205 - Blood and plasma warming device.
§ 864.7280 - Factor V Leiden DNA mutation detection § 864.9225 - Cell-freezing apparatus and reagents for
systems. in vitro diagnostic use.
§ 864.7290 - Factor deficiency test. § 864.9245 - Automated blood cell separator.
§ 864.7300 - Fibrin monomer paracoagulation test. § 864.9275 - Blood bank centrifuge for in vitro
§ 864.7320 - Fibrinogen/fibrin degradation products diagnostic use.
assay. § 864.9285 - Automated cell-washing centrifuge for
§ 864.7340 - Fibrinogen determination system. immuno-hematology.
§ 864.7360 - Erythrocytic glucose-6-phosphate § 864.9300 - Automated Coombs test systems.
dehydrogenase assay. § 864.9320 - Copper sulfate solution for specific
§ 864.7375 - Glutathione reductase assay. gravity determinations.
§ 864.7400 - Hemoglobin A[bdi2] assay. § 864.9400 - Stabilized enzyme solution.
§ 864.7415 - Abnormal hemoglobin assay. § 864.9550 - Lectins and protectins.
§ 864.7425 - Carboxyhemoglobin assay. § 864.9575 - Environmental chamber for storage of
§ 864.7440 - Electrophoretic hemoglobin analysis platelet concentrate.

§ 864.9600 - Potentiating media for in vitro § 890.3500 - External assembled lower limb
diagnostic use. prosthesis.
§ 864.9650 - Quality control kit for blood banking § 890.3520 - Plinth.
reagents. § 890.3610 - Rigid pneumatic structure orthosis.
§ 864.9700 - Blood storage refrigerator and blood § 890.3640 - Arm sling.
storage freezer. § 890.3665 - Congenital hip dislocation abduction
§ 864.9750 - Heat-sealing device. splint.
§ 864.9875 - Transfer set. § 890.3675 - Denis Brown splint.
Subpart K--Products Used In Establishments That § 890.3690 - Powered wheeled stretcher.
Manufacture Human Cells, Tissues, and Cellular and § 890.3700 - Nonpowered communication system.
Tissue-Based Products (HCT/Ps) § 890.3710 - Powered communication system.
§ 864.9900 - Cord blood processing system and § 890.3725 - Powered environmental control
storage container. system.
§ 890.3750 - Mechanical table.
§ 890.3760 - Powered table.
TITLE 21--FOOD AND DRUGS § 890.3790 - Cane, crutch, and walker tips and pads.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 890.3800 - Motorized three-wheeled vehicle.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 890.3825 - Mechanical walker.
SUBCHAPTER H--MEDICAL DEVICES § 890.3850 - Mechanical wheelchair.
PART 890 § 890.3860 - Powered wheelchair.
PHYSICAL MEDICINE DEVICES § 890.3880 - Special grade wheelchair.
Subpart A--General Provisions § 890.3890 - Stair-climbing wheelchair.
§ 890.1 - Scope. § 890.3900 - Standup wheelchair.
§ 890.3 - Effective dates of requirement for § 890.3910 - Wheelchair accessory.
premarket approval. § 890.3920 - Wheelchair component.
§ 890.9 - Limitations of exemptions from section § 890.3930 - Wheelchair elevator.
510(k) of the Federal Food, Drug, and Cosmetic Act § 890.3940 - Wheelchair platform scale.
(the act). Subpart E [Reserved]
Subpart B--Physical Medicine Diagnostic Devices Subpart F--Physical Medicine Therapeutic Devices
§ 890.1175 - Electrode cable. § 890.5050 - Daily activity assist device.
§ 890.1225 - Chronaximeter. § 890.5100 - Immersion hydrobath.
§ 890.1375 - Diagnostic electromyograph. § 890.5110 - Paraffin bath.
§ 890.1385 - Diagnostic electromyograph needle § 890.5125 - Nonpowered sitz bath.
electrode. § 890.5150 - Powered patient transport.
§ 890.1450 - Powered reflex hammer. § 890.5160 - Air-fluidized bed.
§ 890.1575 - Force-measuring platform. § 890.5170 - Powered flotation therapy bed.
§ 890.1600 - Intermittent pressure measurement § 890.5180 - Manual patient rotation bed.
system. § 890.5225 - Powered patient rotation bed.
§ 890.1615 - Miniature pressure transducer. § 890.5250 - Moist steam cabinet.
§ 890.1850 - Diagnostic muscle stimulator. § 890.5275 - Microwave diathermy.
§ 890.1925 - Isokinetic testing and evaluation § 890.5290 - Shortwave diathermy.
system. § 890.5300 - Ultrasonic diathermy.
Subpart C [Reserved] § 890.5350 - Exercise component.
Subpart D--Physical Medicine Prosthetic Devices § 890.5360 - Measuring exercise equipment.
§ 890.3025 - Prosthetic and orthotic accessory. § 890.5370 - Nonmeasuring exercise equipment.
§ 890.3075 - Cane. § 890.5380 - Powered exercise equipment.
§ 890.3100 - Mechanical chair. § 890.5410 - Powered finger exerciser.
§ 890.3110 - Electric positioning chair. § 890.5500 - Infrared lamp.
§ 890.3150 - Crutch. § 890.5525 - Iontophoresis device.
§ 890.3175 - Flotation cushion. § 890.5575 - Powered external limb overload
§ 890.3410 - External limb orthotic component. warning device.
§ 890.3420 - External limb prosthetic component. § 890.5650 - Powered inflatable tube massager.
§ 890.3450 - Upper extremity prosthesis including a § 890.5660 - Therapeutic massager.
simultaneously powered elbow and/or shoulder with § 890.5700 - Cold pack.
greater than two simultaneous powered degrees of § 890.5710 - Hot or cold disposable pack.
freedom and controlled by non-implanted electrical § 890.5720 - Water circulating hot or cold pack.
components. § 890.5730 - Moist heat pack.
§ 890.3475 - Limb orthosis. § 890.5740 - Powered heating pad.
§ 890.3480 - Powered lower extremity exoskeleton. § 890.5760 - Nonpowered lower extremity pressure
§ 890.3490 - Truncal orthosis. wrap.
 § 890.5765 - Pressure-applying device. § 892.1660 - Non-image-intensified fluoroscopic x-
§ 890.5850 - Powered muscle stimulator. ray system.
§ 890.5860 - Ultrasound and muscle stimulator. § 892.1670 - Spot-film device.
§ 890.5880 - Multi-function physical therapy table. § 892.1680 - Stationary x-ray system.
§ 890.5900 - Power traction equipment. § 892.1700 - Diagnostic x-ray high voltage generator.
§ 890.5925 - Traction accessory. § 892.1710 - Mammographic x-ray system.
§ 890.5940 - Chilling unit. § 892.1715 - Full-field digital mammography system.
§ 890.5950 - Powered heating unit. § 892.1720 - Mobile x-ray system.
§ 890.5975 - Therapeutic vibrator. § 892.1730 - Photofluorographic x-ray system.
§ 892.1740 - Tomographic x-ray system.
§ 892.1750 - Computed tomography x-ray system.
TITLE 21--FOOD AND DRUGS § 892.1760 - Diagnostic x-ray tube housing
CHAPTER I--FOOD AND DRUG ADMINISTRATION assembly.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 892.1770 - Diagnostic x-ray tube mount.
SUBCHAPTER H--MEDICAL DEVICES § 892.1820 - Pneumoencephalographic chair.
PART 892 § 892.1830 - Radiologic patient cradle.
RADIOLOGY DEVICES § 892.1840 - Radiographic film.
Subpart A--General Provisions § 892.1850 - Radiographic film cassette.
§ 892.1 - Scope. § 892.1860 - Radiographic film/cassette changer.
§ 892.3 - Effective dates of requirement for § 892.1870 - Radiographic film/cassette changer
premarket approval. programmer.
§ 892.9 - Limitations of exemptions from section § 892.1880 - Wall-mounted radiographic cassette
510(k) of the Federal Food, Drug, and Cosmetic Act holder.
(the act). § 892.1890 - Radiographic film illuminator.
Subpart B--Diagnostic Devices § 892.1900 - Automatic radiographic film processor.
§ 892.1000 - Magnetic resonance diagnostic device. § 892.1910 - Radiographic grid.
§ 892.1100 - Scintillation (gamma) camera. § 892.1920 - Radiographic head holder.
§ 892.1110 - Positron camera. § 892.1940 - Radiologic quality assurance
§ 892.1130 - Nuclear whole body counter. instrument.
§ 892.1170 - Bone densitometer. § 892.1950 - Radiographic anthropomorphic
§ 892.1180 - Bone sonometer. phantom.
§ 892.1200 - Emission computed tomography § 892.1960 - Radiographic intensifying screen.
system. § 892.1970 - Radiographic ECG/respirator
§ 892.1220 - Fluorescent scanner. synchronizer.
§ 892.1300 - Nuclear rectilinear scanner. § 892.1980 - Radiologic table.
§ 892.1310 - Nuclear tomography system. § 892.1990 - Transilluminator for breast evaluation.
§ 892.1320 - Nuclear uptake probe. § 892.2010 - Medical image storage device.
§ 892.1330 - Nuclear whole body scanner. § 892.2020 - Medical image communications device.
§ 892.1350 - Nuclear scanning bed. § 892.2030 - Medical image digitizer.
§ 892.1360 - Radionuclide dose calibrator. § 892.2040 - Medical image hardcopy device.
§ 892.1370 - Nuclear anthropomorphic phantom. § 892.2050 - Picture archiving and communications
§ 892.1380 - Nuclear flood source phantom. system.
§ 892.1390 - Radionuclide rebreathing system. Subparts C-E [Reserved]
§ 892.1400 - Nuclear sealed calibration source. Subpart F--Therapeutic Devices
§ 892.1410 - Nuclear electrocardiograph § 892.5050 - Medical charged-particle radiation
synchronizer. therapy system.
§ 892.1420 - Radionuclide test pattern phantom. § 892.5300 - Medical neutron radiation therapy
§ 892.1540 - Nonfetal ultrasonic monitor. system.
§ 892.1550 - Ultrasonic pulsed doppler imaging § 892.5650 - Manual radionuclide applicator system.
system. § 892.5700 - Remote controlled radionuclide
§ 892.1560 - Ultrasonic pulsed echo imaging system. applicator system.
§ 892.1570 - Diagnostic ultrasonic transducer. § 892.5710 - Radiation therapy beam-shaping block.
§ 892.1600 - Angiographic x-ray system. § 892.5730 - Radionuclide brachytherapy source.
§ 892.1610 - Diagnostic x-ray beam-limiting device. § 892.5740 - Radionuclide teletherapy source.
§ 892.1620 - Cine or spot fluorographic x-ray § 892.5750 - Radionuclide radiation therapy system.
camera. § 892.5770 - Powered radiation therapy patient
§ 892.1630 - Electrostatic x-ray imaging system. support assembly.
§ 892.1640 - Radiographic film marking system. § 892.5780 - Light beam patient position indicator.
§ 892.1650 - Image-intensified fluoroscopic x-ray § 892.5840 - Radiation therapy simulation system.
system. § 892.5900 - X-ray radiation therapy system.

§ 892.5930 - Therapeutic x-ray tube housing § 862.1155 - Human chorionic gonadotropin (HCG)
assembly. test system.
Subpart G--Miscellaneous Devices § 862.1160 - Bicarbonate/carbon dioxide test
§ 892.6500 - Personnel protective shield. system.
§ 862.1163 - Cardiac allograft gene expression
profiling test system.
TITLE 21--FOOD AND DRUGS § 862.1165 - Catecholamines (total) test system.
CHAPTER I--FOOD AND DRUG ADMINISTRATION § 862.1170 - Chloride test system.
DEPARTMENT OF HEALTH AND HUMAN SERVICES § 862.1175 - Cholesterol (total) test system.
SUBCHAPTER H--MEDICAL DEVICES § 862.1177 - Cholylglycine test system.
PART 862 CLINICAL § 862.1180 - Chymotrypsin test system.
CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES § 862.1185 - Compound S (11-deoxycortisol) test
Subpart A--General Provisions system.
§ 862.1 - Scope. § 862.1187 - Conjugated sulfolithocholic acid (SLCG)
§ 862.2 - Regulation of calibrators. test system.
§ 862.3 - Effective dates of requirement for § 862.1190 - Copper test system.
premarket approval. § 862.1195 - Corticoids test system.
§ 862.9 - Limitations of exemptions from section § 862.1200 - Corticosterone test system.
510(k) of the Federal Food, Drug, and Cosmetic Act § 862.1205 - Cortisol (hydrocortisone and
(the act). hydroxycorticosterone) test system.
Subpart B--Clinical Chemistry Test Systems § 862.1210 - Creatine test system.
§ 862.1020 - Acid phosphatase (total or prostatic) § 862.1215 - Creatine phosphokinase/creatine kinase
test system. or isoenzymes test system.
§ 862.1025 - Adrenocorticotropic hormone (ACTH) § 862.1225 - Creatinine test system.
test system. § 862.1230 - Cyclic AMP test system.
§ 862.1030 - Alanine amino transferase (ALT/SGPT) § 862.1235 - Cyclosporine test system.
test system. § 862.1240 - Cystine test system.
§ 862.1035 - Albumin test system. § 862.1245 - Dehydroepiandrosterone (free and
§ 862.1040 - Aldolase test system. sulfate) test system.
§ 862.1045 - Aldosterone test system. § 862.1250 - Desoxycorticosterone test system.
§ 862.1050 - Alkaline phosphatase or isoenzymes § 862.1255 - 2,3-Diphosphoglyceric acid test system.
test system. § 862.1260 - Estradiol test system.
§ 862.1055 - Newborn screening test system for § 862.1265 - Estriol test system.
amino acids, free carnitine, and acylcarnitines using § 862.1270 - Estrogens (total, in pregnancy) test
tandem mass spectrometry. system.
§ 862.1060 - Delta-aminolevulinic acid test system. § 862.1275 - Estrogens (total, nonpregnancy) test
§ 862.1065 - Ammonia test system. system.
§ 862.1070 - Amylase test system. § 862.1280 - Estrone test system.
§ 862.1075 - Androstenedione test system. § 862.1285 - Etiocholanolone test system.
§ 862.1080 - Androsterone test system. § 862.1290 - Fatty acids test system.
§ 862.1085 - Angiotensin I and renin test system. § 862.1295 - Folic acid test system.
§ 862.1090 - Angiotensin converting enzyme (A.C.E.) § 862.1300 - Follicle-stimulating hormone test
test system. system.
§ 862.1095 - Ascorbic acid test system. § 862.1305 - Formiminoglutamic acid (FIGLU) test
§ 862.1100 - Aspartate amino transferase system.
(AST/SGOT) test system. § 862.1310 - Galactose test system.
§ 862.1110 - Bilirubin (total or direct) test system. § 862.1315 - Galactose-1-phosphate uridyl
§ 862.1113 - Bilirubin (total and unbound) in the transferase test system.
neonate test system. § 862.1320 - Gastric acidity test system.
§ 862.1115 - Urinary bilirubin and its conjugates § 862.1325 - Gastrin test system.
(nonquantitative) test system. § 862.1330 - Globulin test system.
§ 862.1117 - B-type natriuretic peptide test system. § 862.1335 - Glucagon test system.
§ 862.1118 - Biotinidase test system. § 862.1340 - Urinary glucose (nonquantitative) test
§ 862.1120 - Blood gases (PCO2, PO2) and blood pH system.
test system. § 862.1345 - Glucose test system.
§ 862.1130 - Blood volume test system. § 862.1350 - Continuous glucose monitor secondary
§ 862.1135 - C-peptides of proinsulin test system. display.
§ 862.1140 - Calcitonin test system. § 862.1360 - Gamma-glutamyl transpeptidase and
§ 862.1145 - Calcium test system. isoenzymes test system.
§ 862.1150 - Calibrator. § 862.1365 - Glutathione test system.
 § 862.1370 - Human growth hormone test system. § 862.1605 - Pregnanediol test system.
§ 862.1373 - Hemoglobin A1c test system. § 862.1610 - Pregnanetriol test system.
§ 862.1375 - Histidine test system. § 862.1615 - Pregnenolone test system.
§ 862.1377 - Urinary homocystine (nonquantitative) § 862.1620 - Progesterone test system.
test system. § 862.1625 - Prolactin (lactogen) test system.
§ 862.1380 - Hydroxybutyric dehydrogenase test § 862.1630 - Protein (fractionation) test system.
system. § 862.1635 - Total protein test system.
§ 862.1385 - 17-Hydroxycorticosteroids (17- § 862.1640 - Protein-bound iodine test system.
ketogenic steroids) test system. § 862.1645 - Urinary protein or albumin
§ 862.1390 - 5-Hydroxyindole acetic acid/serotonin (nonquantitative) test system.
test system. § 862.1650 - Pyruvate kinase test system.
§ 862.1395 - 17-Hydroxyprogesterone test system. § 862.1655 - Pyruvic acid test system.
§ 862.1400 - Hydroxyproline test system. § 862.1660 - Quality control material (assayed and
§ 862.1405 - Immunoreactive insulin test system. unassayed).
§ 862.1410 - Iron (non-heme) test system. § 862.1665 - Sodium test system.
§ 862.1415 - Iron-binding capacity test system. § 862.1670 - Sorbitol dehydrogenase test system.
§ 862.1420 - Isocitric dehydrogenase test system. § 862.1675 - Blood specimen collection device.
§ 862.1430 - 17-Ketosteroids test system. § 862.1678 - Tacrolimus test system.
§ 862.1435 - Ketones (nonquantitative) test system. § 862.1680 - Testosterone test system.
§ 862.1440 - Lactate dehydrogenase test system. § 862.1685 - Thyroxine-binding globulin test system.
§ 862.1445 - Lactate dehydrogenase isoenzymes test § 862.1690 - Thyroid stimulating hormone test
system. system.
§ 862.1450 - Lactic acid test system. § 862.1695 - Free thyroxine test system.
§ 862.1455 - Lecithin/sphingomyelin ratio in amniotic § 862.1700 - Total thyroxine test system.
fluid test system. § 862.1705 - Triglyceride test system.
§ 862.1460 - Leucine aminopeptidase test system. § 862.1710 - Total triiodothyronine test system.
§ 862.1465 - Lipase test system. § 862.1715 - Triiodothyronine uptake test system.
§ 862.1470 - Lipid (total) test system. § 862.1720 - Triose phosphate isomerase test
§ 862.1475 - Lipoprotein test system. system.
§ 862.1485 - Luteinizing hormone test system. § 862.1725 - Trypsin test system.
§ 862.1490 - Lysozyme (muramidase) test system. § 862.1730 - Free tyrosine test system.
§ 862.1495 - Magnesium test system. § 862.1770 - Urea nitrogen test system.
§ 862.1500 - Malic dehydrogenase test system. § 862.1775 - Uric acid test system.
§ 862.1505 - Mucopolysaccharides (nonquantitative) § 862.1780 - Urinary calculi (stones) test system.
test system. § 862.1785 - Urinary urobilinogen (nonquantitative)
§ 862.1509 - Methylmalonic acid (nonquantitative) test system.
test system. § 862.1790 - Uroporphyrin test system.
§ 862.1510 - Nitrite (nonquantitative) test system. § 862.1795 - Vanilmandelic acid test system.
§ 862.1515 - Nitrogen (amino-nitrogen) test system. § 862.1805 - Vitamin A test system.
§ 862.1520 - 5'-Nucleotidase test system. § 862.1810 - Vitamin B[bdi1][bdi2] test system.
§ 862.1530 - Plasma oncometry test system. § 862.1815 - Vitamin E test system.
§ 862.1535 - Ornithine carbamyl transferase test § 862.1820 - Xylose test system.
system. § 862.1825 - Vitamin D test system.
§ 862.1540 - Osmolality test system. Subpart C--Clinical Laboratory Instruments
§ 862.1542 - Oxalate test system. § 862.2050 - General purpose laboratory equipment
§ 862.1545 - Parathyroid hormone test system. labeled or promoted for a specific medical use.
§ 862.1550 - Urinary pH (nonquantitative) test § 862.2100 - Calculator/data processing module for
system. clinical use.
§ 862.1555 - Phenylalanine test system. § 862.2140 - Centrifugal chemistry analyzer for
§ 862.1560 - Urinary phenylketones clinical use.
(nonquantitative) test system. § 862.2150 - Continuous flow sequential multiple
§ 862.1565 - 6-Phosphogluconate dehydrogenase chemistry analyzer for clinical use.
test system. § 862.2160 - Discrete photometric chemistry
§ 862.1570 - Phosphohexose isomerase test system. analyzer for clinical use.
§ 862.1575 - Phospholipid test system. § 862.2170 - Micro chemistry analyzer for clinical
§ 862.1580 - Phosphorus (inorganic) test system. use.
§ 862.1585 - Human placental lactogen test system. § 862.2230 - Chromatographic separation material
§ 862.1590 - Porphobilinogen test system. for clinical use.
§ 862.1595 - Porphyrins test system. § 862.2250 - Gas liquid chromatography system for
§ 862.1600 - Potassium test system. clinical use.

§ 862.2260 - High pressure liquid chromatography § 862.3555 - Lidocaine test system.

system for clinical use. § 862.3560 - Lithium test system.
§ 862.2265 - High throughput genomic sequence § 862.3580 - Lysergic acid diethylamide (LSD) test
analyzer for clinical use. system.
§ 862.2270 - Thin-layer chromatography system for § 862.3600 - Mercury test system.
clinical use. § 862.3610 - Methamphetamine test system.
§ 862.2300 - Colorimeter, photometer, or § 862.3620 - Methadone test system.
spectrophotometer for clinical use. § 862.3630 - Methaqualone test system.
§ 862.2310 - Clinical sample concentrator. § 862.3640 - Morphine test system.
§ 862.2320 - Beta or gamma counter for clinical use. § 862.3645 - Neuroleptic drugs radioreceptor assay
§ 862.2400 - Densitometer/scanner (integrating, test system.
reflectance, TLC, or radiochromatogram) for clinical § 862.3650 - Opiate test system.
use. § 862.3660 - Phenobarbital test system.
§ 862.2485 - Electrophoresis apparatus for clinical § 862.3670 - Phenothiazine test system.
use. § 862.3680 - Primidone test system.
§ 862.2500 - Enzyme analyzer for clinical use. § 862.3700 - Propoxyphene test system.
§ 862.2540 - Flame emission photometer for clinical § 862.3750 - Quinine test system.
use. § 862.3830 - Salicylate test system.
§ 862.2560 - Fluorometer for clinical use. § 862.3840 - Sirolimus test system.
§ 862.2570 - Instrumentation for clinical multiplex § 862.3850 - Sulfonamide test system.
test systems. § 862.3870 - Cannabinoid test system.
§ 862.2680 - Microtitrator for clinical use. § 862.3880 - Theophylline test system.
§ 862.2700 - Nephelometer for clinical use. § 862.3900 - Tobramycin test system.
§ 862.2720 - Plasma oncometer for clinical use. § 862.3910 - Tricyclic antidepressant drugs test
§ 862.2730 - Osmometer for clinical use. system.
§ 862.2750 - Pipetting and diluting system for clinical § 862.3950 - Vancomycin test system.
use.
§ 862.2800 - Refractometer for clinical use.
§ 862.2850 - Atomic absorption spectrophotometer
for clinical use.
§ 862.2860 - Mass spectrometer for clinical use.
§ 862.2900 - Automated urinalysis system.
§ 862.2920 - Plasma viscometer for clinical use.
Subpart D--Clinical Toxicology Test Systems
§ 862.3030 - Acetaminophen test system.
§ 862.3035 - Amikacin test system.
§ 862.3040 - Alcohol test system.
§ 862.3050 - Breath-alcohol test system.
§ 862.3080 - Breath nitric oxide test system.
§ 862.3100 - Amphetamine test system.
§ 862.3110 - Antimony test system.
§ 862.3120 - Arsenic test system.
§ 862.3150 - Barbiturate test system.
§ 862.3170 - Benzodiazepine test system.
§ 862.3200 - Clinical toxicology calibrator.
§ 862.3220 - Carbon monoxide test system.
§ 862.3240 - Cholinesterase test system.
§ 862.3250 - Cocaine and cocaine metabolite test
system.
§ 862.3270 - Codeine test system.
§ 862.3280 - Clinical toxicology control material.
§ 862.3300 - Digitoxin test system.
§ 862.3320 - Digoxin test system.
§ 862.3350 - Diphenylhydantoin test system.
§ 862.3360 - Drug metabolizing enzyme genotyping
system.
§ 862.3380 - Ethosuximide test system.
§ 862.3450 - Gentamicin test system.
§ 862.3520 - Kanamycin test system.
§ 862.3550 - Lead test system.