FDA product codes

The device classification tree, in product code order.

FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.

Data as of 2026-10-05, the FDA export date. FDA product classification database

Review panels

6,880 codes

FDA review panels and the number of ingested product codes in each
Review panel	Panel code	Product codes
Anesthesiology	AN	262
Cardiovascular	CV	437
Clinical Chemistry	CH	527
Clinical Toxicology	TX	338
Dental	DE	352
Ear, Nose, Throat	EN	269
Gastroenterology, Urology	GU	614
General Hospital	HO	394
General, Plastic Surgery	SU	562
Hematology	HE	281
Immunology	IM	278
Medical Genetics	MG	7
Microbiology	MI	554
Neurology	NE	291
Obstetrics/Gynecology	OB	269
Ophthalmic	OP	345
Orthopedic	OR	349
Pathology	PA	325
Physical Medicine	PM	210
Radiology	RA	216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 29 of 71

FDA product codes, page 29 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
JIP	Blood, Occult, Enzymatic Method, In Urine	Class II	21 CFR 864.6550	0	0
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Class I	21 CFR 862.1645	13	1
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Class I	21 CFR 862.1645	38	7
JIS	Calibrator, Primary	Class II	21 CFR 862.1150	130	21
JIT	Calibrator, Secondary	Class II	21 CFR 862.1150	245	55
JIW	Calibrator, Surrogate	Class II	21 CFR 862.1150	17	0
JIX	Calibrator, Multi-Analyte Mixture	Class II	21 CFR 862.1150	302	73
JIY	Photometric Method, Iron (Non-Heme)	Class I	21 CFR 862.1410	67	19
JIZ	Atomic Absorption, Iron (Non-Heme)	Class I	21 CFR 862.1410	0	0
JJA	Radio-Labeled Iron Method, Iron (Non-Heme)	Class I	21 CFR 862.1410	4	0
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Class I	21 CFR 862.1115	5	0
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Class I	21 CFR 862.2150	32	1
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Class I	21 CFR 862.2160	208	561
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Class I	21 CFR 862.2170	57	13
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use	Class I	21 CFR 862.2140	30	1
JJH	Clinical Sample Concentrator	Class I	21 CFR 862.2310	15	31
JJI	Analyzer, Enzyme, For Clinical Use	Class I	21 CFR 862.2500	8	1
JJJ	Counter (Beta, Gamma) For Clinical Use	Class I	21 CFR 862.2320	63	14
JJK	Oncometer, Plasma, For Clinical Use	Class I	21 CFR 862.2720	4	0
JJL	Plasma Viscometer For Clinical Use	Class I	21 CFR 862.2920	1	0
JJM	Osmometer For Clinical Use	Class I	21 CFR 862.2730	12	3
JJN	Apparatus, Electrophoresis, For Clinical Use	Class I	21 CFR 862.2485	34	1
JJO	Flame Emission Photometer For Clinical Use	Class I	21 CFR 862.2540	22	0
JJP	Electrode, Ion Selective (Non-Specified)	Class I	21 CFR 862.2050	3	0
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Class I	21 CFR 862.2300	258	17
JJR	Electrolyte Controls (Assayed And Unassayed)	Class I	21 CFR 862.1660	17	0
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Class I	21 CFR 862.1660	67	1
JJT	Enzyme Controls (Assayed And Unassayed)	Class I	21 CFR 862.1660	97	2
JJW	Urinalysis Controls (Assayed And Unassayed)	Class I	21 CFR 862.1660	61	22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	21 CFR 862.1660	493	42
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Class I	21 CFR 862.1660	673	91
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	21 CFR 862.1675	237	170
JKB	Radioimmunoassay, Compound S (11-Deoxycortisol)	Class I	21 CFR 862.1185	1	0
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Class I	21 CFR 862.1245	28	7
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Class I	21 CFR 862.1135	10	5
JKF	Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge	Class I	21 CFR 862.1380	2	0
JKG	L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase	Class I	21 CFR 862.1420	1	0
JKH	Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen	Class I	21 CFR 862.1420	1	0
JKJ	Fluorometric Measurement, Porphyrins	Class I	21 CFR 862.1595	3	0
JKL	Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry	Class I	21 CFR 862.1060	2	0
JKM	Immunochemical, Bence-Jones Protein	Class II	21 CFR 866.5150	4	0
JKP	Chromium-51, Blood Volume	Class I	21 CFR 862.1130	1	0
JKQ	Gold Chloride (Colorimetric), Bromide	Class II	21 CFR 862.3645	0	0
JKR	Radioimmunoassay, Calcitonin	Class II	21 CFR 862.1140	20	1
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Class I	21 CFR 862.3220	8	1
JKT	Gas Chromatograph, Carbon-Monoxide	Class I	21 CFR 862.3220	2	0
JKW	N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin	Class I	21 CFR 862.1180	0	0
JKX	N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin	Class I	21 CFR 862.1180	0	0
JKY	Oxalydihydrazide (Spectroscopic), Copper	Class I	21 CFR 862.1190	0	0
JKZ	Diethyldithiocarbamate (Colorimetric), Copper	Class I	21 CFR 862.1190	0	1
JLA	Conversion To Creatinine, Creatine	Class I	21 CFR 862.1210	2	1
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Class I	21 CFR 862.1210	3	2
JLC	Nitroprusside Reaction (Qualitative, Urine), Cystine	Class I	21 CFR 862.1240	2	0
JLD	Chromatographic, Cystine	Class I	21 CFR 862.1240	0	0
JLE	Radioimmunoassay, Desoxycorticosterone	Class I	21 CFR 862.1250	0	0
JLF	Radioimmunoassay, Etiocholanolone	Class I	21 CFR 862.1285	0	0
JLG	Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids	Class I	21 CFR 862.1290	2	1
JLH	Titrimetric, Fatty Acids	Class I	21 CFR 862.1290	1	1
JLI	Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid	Class I	21 CFR 862.1305	0	0
JLJ	Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate	Class II	21 CFR 862.1315	1	1
JLK	Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity	Class I	21 CFR 862.1320	0	0
JLL	Tubeless Analysis, Gastric Acidity	Class I	21 CFR 862.1320	0	0
JLM	Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase	Class II	21 CFR 864.7360	1	0
JLN	Chromatographic, Glutathione	Class I	21 CFR 862.1365	0	0
JLO	Enzymatic (Glutathione Reductase), Glutathione	Class I	21 CFR 862.1365	0	0
JLP	Spectrophotometric Method, Pregnanediol	Class I	21 CFR 862.1605	1	0
JLQ	Spectrophotometric Method, Pregnanetriol	Class I	21 CFR 862.1610	0	0
JLR	Gas Chromatography, Pregnanetriol	Class I	21 CFR 862.1610	0	0
JLS	Radioimmunoassay, Progesterone	Class I	21 CFR 862.1620	57	21
JLT	Acid, Pyruvic, Enzymatic (U.V.)	Class I	21 CFR 862.1655	0	0
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Class II	21 CFR 862.1690	242	46
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Class I	21 CFR 862.1395	19	3
JLY	Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid	Class I	21 CFR 862.1255	0	0
JLZ	Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid	Class I	21 CFR 862.1255	0	0
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Class I	21 CFR 862.1095	3	0
JMB	Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase	Class II	21 CFR 864.7360	1	0
JMC	Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase	Class II	21 CFR 864.7360	0	0
JMD	Radioimmunoassay, Total Estrogens, Nonpregnancy	Class I	21 CFR 862.1275	2	0
JME	Radioimmunoassay, Glucagon	Class I	21 CFR 862.1335	3	0
JMF	Radioimmunoassay, Human Placental Lactogen	Class II	21 CFR 862.1585	11	0
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Class II	21 CFR 866.5340	24	5
JMH	Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase	Class II	21 CFR 864.7375	0	0
JMI	Chromatographic, Histidine	Class I	21 CFR 862.1375	0	0
JMJ	Microbiological, Histidine	Class I	21 CFR 862.1375	0	0
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	Class I	21 CFR 862.1380	16	0
JMM	Column Chromatography & Color Development, Hydroxyproline	Class I	21 CFR 862.1400	21	2
JMN	Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline	Class I	21 CFR 862.1400	0	0
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Class I	21 CFR 862.1415	46	7
JMQ	M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)	Class I	21 CFR 862.1490	0	0
JMR	Immunochemical, Lysozyme (Muramidase)	Class I	21 CFR 862.1490	0	0
JMS	Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase	Class I	21 CFR 862.1500	0	0
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Class I	21 CFR 862.1510	13	2
JMW	2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)	Class I	21 CFR 862.1515	0	0
JMX	Ninhydrin, Nitrogen (Amino-Nitrogen)	Class I	21 CFR 862.1515	2	0
JMY	Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase	Class I	21 CFR 862.1535	0	0
JMZ	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	Class I	21 CFR 862.1540	2	0
JNA	Vapor Pressure, Osmolality Of Serum & Urine	Class I	21 CFR 862.1540	0	0
JNB	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	Class II	21 CFR 862.1555	15	2
JNC	Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine	Class II	21 CFR 862.1555	0	0
JND	Nadp Reduction, 6-Phosphogluconate Dehydrogenase	Class I	21 CFR 862.1565	0	0