Clinical Chemistry

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Code	Device name	Class	21 CFR	510(k) (3y)
CCY	Zimmerman (Spectrophotometric), 17-Ketosteroids	Class 1	21 CFR 862.1430	1
CCZ	Zimmerman/Norymberski, 17-Ketogenic Steroids	Class 1	21 CFR 862.1385	1
CDA	Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Seroton	Class 1	21 CFR 862.1390	3
CDB	Porter Silber Hydrazone, 17-Hydroxycorticosteroids	Class 1	21 CFR 862.1385	2
CDC	L-Leucyl B-Naphthylamide, Leucine Aminopeptidase	Class 1	21 CFR 862.1460
CDD	Radioassay, Vitamin B12	Class 2	21 CFR 862.1810	78
CDE	Chromatographic Separation/Zimmerman, 17-Ketosteroids	Class 1	21 CFR 862.1430
CDF	Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin	Class 1	21 CFR 862.1795	12
CDG	Chromatography Separation/Zimmerman 17-Ketogenic Steroids	Class 1	21 CFR 862.1385	1
CDH	Acid, Uric, Phosphotungstate Reduction	Class 1	21 CFR 862.1775	15
CDK	Acid, Vanilmandelic, Electrophoretic Separation	Class 1	21 CFR 862.1795
CDL	Berthelot Indophenol, Urea Nitrogen	Class 2	21 CFR 862.1770	16
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Class 1	21 CFR 862.1785	9
CDN	Urease, Photometric, Urea Nitrogen	Class 2	21 CFR 862.1770	16
CDO	Acid, Uric, Uricase (U.V.)	Class 1	21 CFR 862.1775	31
CDP	Radioimmunoassay, Total Triiodothyronine	Class 2	21 CFR 862.1710	144
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Class 2	21 CFR 862.1770	117
CDR	1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine	Class 1	21 CFR 862.1730	1
CDS	Electrode, Ion Specific, Urea Nitrogen	Class 2	21 CFR 862.1770	15
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Class 1	21 CFR 862.1705	151
CDW	Diacetyl-Monoxime, Urea Nitrogen	Class 2	21 CFR 862.1770	21
CDX	Radioimmunoassay, Total Thyroxine	Class 2	21 CFR 862.1700	121
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Class 1	21 CFR 862.1680	89
CEA	Tlc Chromatographic Separation Triglycerides	Class 1	21 CFR 862.1705
CEC	Radioimmunoassay, Free Thyroxine	Class 2	21 CFR 862.1695	92
CED	5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase	Class 1	21 CFR 862.1520	9
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Class 2	21 CFR 862.1685	25
CEF	Electrophoretic, Protein Fractionation	Class 1	21 CFR 862.1630	29
CEI	Uranyl Acetate/Zinc Acetate, Sodium	Class 2	21 CFR 862.1665	4
CEJ	Tetraphenyl Borate, Colorimetry, Potassium	Class 2	21 CFR 862.1600	16
CEK	Biuret (Colorimetric), Total Protein	Class 2	21 CFR 862.1635	116
CEL	Ammonium Molybdate And Ammonium Vanadate, Phospholipids	Class 1	21 CFR 862.1575	3
CEM	Electrode, Ion Specific, Potassium	Class 2	21 CFR 862.1600	89
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Class 1	21 CFR 862.1550	11
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Class 1	21 CFR 862.1580	105
CEP	Radioimmunoassay, Luteinizing Hormone	Class 1	21 CFR 862.1485	143
CEQ	Molybdenum Blue Method, Phospholipids	Class 1	21 CFR 862.1575	1
CER	2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase	Class 2	21 CFR 862.1440	1
CES	Chromogenesis, Phenylketones (Urinary, Non-Quant.)	Class 1	21 CFR 862.1560
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Class 1	21 CFR 862.1465	15
CEW	Radioimmunoassay, Parathyroid Hormone	Class 2	21 CFR 862.1545	86
CEX	Chromatographic Separation, Lactate Dehydrogenase Isoenzymes	Class 2	21 CFR 862.1445	8
CFA	Electrode, Ion Specific, Magnesium	Class 1	21 CFR 862.1495	2
CFB	Chromatographic Derivative, Total Lipids	Class 1	21 CFR 862.1470
CFD	Sulfophosphovanillin, Colorimetry, Total Lipids	Class 1	21 CFR 862.1470	4
CFE	Electrophoretic, Lactate Dehydrogenase Isoenzymes	Class 2	21 CFR 862.1445	28
CFG	Oil Emulsion/Thymolphthalein (Titrimetric), Lipase	Class 1	21 CFR 862.1465	2
CFH	Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase	Class 2	21 CFR 862.1440	13
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Class 2	21 CFR 862.1440	111
CFL	Radioimmunoassay, Human Growth Hormone	Class 1	21 CFR 862.1370	36
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Class 1	21 CFR 862.1410	21
CFO	Titrimetric, Magnesium	Class 1	21 CFR 862.1495
CFP	Radioimmunoassay, Immunoreactive Insulin	Class 1	21 CFR 862.1405	27
CFR	Hexokinase, Glucose	Class 2	21 CFR 862.1345	145
CFT	Radioimmunoassay, Prolactin (Lactogen)	Class 1	21 CFR 862.1625	80
CFW	Copper Reduction, Glucose	Class 2	21 CFR 862.1345
CGA	Glucose Oxidase, Glucose	Class 2	21 CFR 862.1345	401
CGC	Radioimmunoassay, Gastrin	Class 1	21 CFR 862.1325	10
CGD	Ferricyanide, Glucose	Class 2	21 CFR 862.1345
CGE	Orthotoluidine, Glucose	Class 2	21 CFR 862.1345	12
CGF	Radioimmunoassay, Estrone	Class 1	21 CFR 862.1280	4
CGH	Electrophoretic, Globulin	Class 1	21 CFR 862.1330
CGI	Radioimmunoassay, Estriol	Class 1	21 CFR 862.1265	42
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Class 1	21 CFR 862.1300	88
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Class 2	21 CFR 862.1225	8
CGN	Acid, Folic, Radioimmunoassay	Class 2	21 CFR 862.1295	64
CGO	Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol	Class 1	21 CFR 862.1175	11
CGR	Radioimmunoassay, Cortisol	Class 2	21 CFR 862.1205	84
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Class 2	21 CFR 862.1215	123
CGT	Radioimmunoassay, Cyclic Gmp	Class 2	21 CFR 862.1230
CGX	Alkaline Picrate, Colorimetry, Creatinine	Class 2	21 CFR 862.1225	159
CGZ	Electrode, Ion-Specific, Chloride	Class 2	21 CFR 862.1170	38
CHA	Radioimmunoassay, Corticosterone	Class 1	21 CFR 862.1200
CHC	Titrimetric Permanganate And Bromophenol Blue, Calcium	Class 2	21 CFR 862.1145
CHD	Acid, Ferric Ion-Sulfuric, Cholesterol	Class 1	21 CFR 862.1175	3
CHE	Radioimmunoassay, Corticoids	Class 1	21 CFR 862.1195
CHG	Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride	Class 2	21 CFR 862.1170	3
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Class 1	21 CFR 862.1175	230
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Class 1	21 CFR 862.1465	20
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Class 2	21 CFR 862.1170	53
CHK	Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride	Class 2	21 CFR 862.1170	1
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Class 2	21 CFR 862.1120	188
CHM	Radioimmunoassay, Total Estrogens In Pregnancy	Class 1	21 CFR 862.1270
CHO	Radioimmunoassay, Cyclic Amp	Class 2	21 CFR 862.1230	6
CHP	Radioimmunoassay, Estradiol	Class 1	21 CFR 862.1260	50
CHQ	Chromatographic/Fluorometric Method, Catecholamines	Class 1	21 CFR 862.1165	10
CHR	Titrimetric Phenol Red, Carbon-Dioxide	Class 2	21 CFR 862.1160
CHS	Coulometric Method, Carbon-Dioxide	Class 2	21 CFR 862.1160	6
CHT	Electrophoretic Method, Catecholamines	Class 1	21 CFR 862.1165	2
CHW	Titrimetric With Edta And Indicator, Calcium	Class 2	21 CFR 862.1145	3
CHZ	Di (O-Hydroxyphenylimine) Ethane, Calcium	Class 2	21 CFR 862.1145	1
CIA	Methylthymol Blue, Calcium	Class 2	21 CFR 862.1145	5
CIB	Radioimmunoassay, Angiotensin I And Renin	Class 2	21 CFR 862.1085	16
CIC	Cresolphthalein Complexone, Calcium	Class 2	21 CFR 862.1145	99
CID	Alizarin Sulfonate, Calcium	Class 2	21 CFR 862.1145	2
CIE	Volumetric/Manometric, Carbon-Dioxide	Class 2	21 CFR 862.1160	7
CIF	Vanillin Pyruvate, Ast/Sgot	Class 2	21 CFR 862.1100	1
CIG	Diazo Colorimetry, Bilirubin	Class 2	21 CFR 862.1110	235
CIJ	Saccharogenic, Amylase	Class 2	21 CFR 862.1070	31
CIK	Radial Diffusion, Amylase	Class 2	21 CFR 862.1070
CIL	Cresol Red Colorimetry, Carbon-Dioxide	Class 2	21 CFR 862.1160	4
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Class 2	21 CFR 862.1050	26
CIO	Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	11
CIQ	Diazo, Ast/Sgot	Class 2	21 CFR 862.1100	7
CIS	Hydrazone Colorimetry, Ast/Sgot	Class 2	21 CFR 862.1100	5
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Class 2	21 CFR 862.1100	139
CIW	Starch-Dye Bound Polymer, Amylase	Class 2	21 CFR 862.1070	8
CIX	Bromcresol Green Dye-Binding, Albumin	Class 2	21 CFR 862.1035	120
CIY	Radioimmunoassay, Androsterone	Class 1	21 CFR 862.1080	1
CIZ	Radioimmunoassay, Androstenedione	Class 1	21 CFR 862.1075	10
CJA	Amyloclastic, Amylase	Class 2	21 CFR 862.1070	10
CJB	Chromatographic Separation/Radioimmunoassay, Aldosterone	Class 2	21 CFR 862.1045
CJC	Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase	Class 1	21 CFR 862.1040
CJD	Nitrosalicylate Reduction, Amylase	Class 2	21 CFR 862.1070	1
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	124
CJF	Tetrabromophenolphthalein, Albumin	Class 2	21 CFR 862.1035	1
CJG	Tetrabromo-M-Cresolsulfonphthalein, Albumin	Class 2	21 CFR 862.1035	1
CJH	Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	1
CJI	Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050
CJJ	Diazo, Alt/Sgpt	Class 1	21 CFR 862.1030	2
CJK	Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	1
CJL	Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	1
CJM	Radioimmunoassay, Aldosterone	Class 2	21 CFR 862.1045	12
CJN	Acid Phosphatase, Nitrophenylphosphate	Class 2	21 CFR 862.1020	1
CJO	Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	4
CJQ	Radial Immunodiffusion, Albumin	Class 2	21 CFR 862.1035	1
CJR	Acid Phosphatase, Thymol Blue Monophosphate	Class 2	21 CFR 862.1020	2
CJT	Hydrazone Colorimetry, Aldolase	Class 1	21 CFR 862.1040	1
CJW	Bromcresol Purple Dye-Binding, Albumin	Class 2	21 CFR 862.1035	18
CJX	Acid Phosphatase, Disodium Phenylphosphate	Class 2	21 CFR 862.1020
CJY	Azo Dye, Calcium	Class 2	21 CFR 862.1145	47
CJZ	Acid, Hydroxyazobenzene-Benzoic, Albumin	Class 2	21 CFR 862.1035
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Class 1	21 CFR 862.1030	127
CKB	Acid Phosphatase, Naphthyl Phosphate	Class 2	21 CFR 862.1020	24
CKC	Vanillin Pyruvate, Alt/Sgpt	Class 1	21 CFR 862.1030	2
CKD	Hydrazone Colorimetry, Alt/Sgpt	Class 1	21 CFR 862.1030	11
CKE	Acid Phosphatase, Thymolphthale Inmonophosphate	Class 2	21 CFR 862.1020	9
CKF	Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	Class 2	21 CFR 862.1050	2
CKG	Radioimmunoassay, Acth	Class 2	21 CFR 862.1025	30
CKH	Acid Phosphatase, Beta Glycerophosphate	Class 2	21 CFR 862.1020
DHA	System, Test, Human Chorionic Gonadotropin	Class 2	21 CFR 862.1155	72
DII	Columns, Glc	Class 1	21 CFR 862.2250	5
DJA	Column Supports, Glc	Class 1	21 CFR 862.2250	1
DJO	Indicator, Cellulose Fluorescent, Tlc	Class 1	21 CFR 862.2270
DJS	U.V. Light, Tlc	Class 1	21 CFR 862.2270	1
DJY	Ion-Exchange Chromatography	Class 1	21 CFR 862.2230	11
DKG	Plate, Cellulose, Tlc	Class 1	21 CFR 862.2270	1
DKK	Tanks, Developing, Tlc	Class 1	21 CFR 862.2270	1
DKO	Adsorbents, Ion-Exchange	Class 1	21 CFR 862.2230	1
DKS	Plate, Silica Gel, Tlc	Class 1	21 CFR 862.2270
DKY	Indicator, Alumina Fluorescent, Tlc	Class 1	21 CFR 862.2270
DLC	Atomizer, Tlc	Class 1	21 CFR 862.2270
DLG	Coating, Liquid, Glc	Class 1	21 CFR 862.2250	7
DLO	Indicator, Silica Gel Fluorescent, Tlc	Class 1	21 CFR 862.2270
DLY	Plate, Alumina, Tlc	Class 1	21 CFR 862.2270
DMG	Papers, Ion	Class 1	21 CFR 862.2230
DMS	Gases, Glc	Class 1	21 CFR 862.2250
DMZ	Liquid Chromatography, Adsorbent	Class 1	21 CFR 862.2260	1
DNH	Resins, Ion-Exchange, Liquid Chromatography	Class 1	21 CFR 862.2260	1
DOP	Mass Spectrometer, Clinical Use	Class 1	21 CFR 862.2860	10
DPA	Apparatus, General Use, Thin Layer Chromatography	Class 1	21 CFR 862.2270	5
DPM	Columns, Liquid Chromatography	Class 1	21 CFR 862.2260	16
GIM	Tubes, Vacuum Sample, With Anticoagulant	Class 2	21 CFR 862.1675	39
GJE	Tray, Blood Collection	Class 2	21 CFR 862.1675	7
GLE	Mixer, Blood Tube	Class 1	21 CFR 862.2050	5
JBS	Timer, General Laboratory	Class 1	21 CFR 862.2050
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Class 2	21 CFR 862.1020	45
JFJ	Catalytic Methods, Amylase	Class 2	21 CFR 862.1070	99
JFL	Ph Rate Measurement, Carbon-Dioxide	Class 2	21 CFR 862.1160	28
JFM	Enzymatic Method, Bilirubin	Class 2	21 CFR 862.1110	11
JFN	Atomic Absorption, Calcium	Class 2	21 CFR 862.1145	3
JFO	Fluorometric, Calcium	Class 2	21 CFR 862.1145	1
JFP	Electrode, Ion Specific, Calcium	Class 2	21 CFR 862.1145	29
JFS	Coulometric, Chloride	Class 2	21 CFR 862.1170	19
JFT	Fluorometric, Cortisol	Class 2	21 CFR 862.1205	20
JFY	Enzymatic Method, Creatinine	Class 2	21 CFR 862.1225	49
JGC	Tryptophan Measurement (Colorimetric), Globulin	Class 1	21 CFR 862.1330
JGD	Nephelometric Method, Globulin	Class 1	21 CFR 862.1330
JGE	Turbidimetric Method, Globulin	Class 1	21 CFR 862.1330	1
JGF	Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes	Class 2	21 CFR 862.1445	6
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Class 1	21 CFR 862.1460	2
JGI	Atomic Absorption, Magnesium	Class 1	21 CFR 862.1495
JGJ	Photometric Method, Magnesium	Class 1	21 CFR 862.1495	90
JGK	Ferric Chloride, Phenylketones (Urinary, Non-Quant.)	Class 1	21 CFR 862.1560
JGM	Flame Photometry, Potassium	Class 2	21 CFR 862.1600	5
JGP	Lowry (Colorimetric), Total Protein	Class 2	21 CFR 862.1635	5
JGQ	Turbidimetric, Total Protein	Class 2	21 CFR 862.1635	13
JGR	Refractometric, Total Protein	Class 2	21 CFR 862.1635
JGS	Electrode, Ion Specific, Sodium	Class 2	21 CFR 862.1665	162
JGT	Flame Photometry, Sodium	Class 2	21 CFR 862.1665	8
JGW	Fluorometric Method, Triglycerides	Class 1	21 CFR 862.1705	3
JGX	Turbidimetric Method, Triglycerides	Class 1	21 CFR 862.1705	1
JGY	Colorimetric Method, Triglycerides	Class 1	21 CFR 862.1705	22
JGZ	O-Phthalaldehyde, Urea Nitrogen	Class 2	21 CFR 862.1770	11
JHA	Acid, Uric, Uricase (Gasometric)	Class 1	21 CFR 862.1775
JHC	Acid, Uric, Uricase (Oxygen Rate)	Class 1	21 CFR 862.1775	1
JHD	Fluorometric Method, 17-Hydroxycorticosteroids	Class 1	21 CFR 862.1385
JHE	Radioassay, 17-Hydroxycorticosteroids	Class 1	21 CFR 862.1385
JHF	Colorimetric Method, Lecithin/Sphingomyelin Ratio	Class 2	21 CFR 862.1455	2
JHG	Chromatographic Separation, Lecithin/Sphingomyelin Ratio	Class 2	21 CFR 862.1455	7