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U.S. Department of Health and Human Services

Product Classification
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510(K) Exempt Device Class 1
 
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CJJ
diazo, alt/sgpt Alanine amino transferase (ALT/SGPT) tes...
862.1030 1
CKA
nadh oxidation/nad reduction, alt/sgpt Alanine amino transferase (ALT/SGPT) tes...
862.1030 1
CKC
vanillin pyruvate, alt/sgpt Alanine amino transferase (ALT/SGPT) tes...
862.1030 1
CKD
hydrazone colorimetry, alt/sgpt Alanine amino transferase (ALT/SGPT) tes...
862.1030 1
CJC
fructose-1, 6-diphosphate and nadh (u.v.), aldolas ... Aldolase test system
862.1040 1
CJT
hydrazone colorimetry, aldolase Aldolase test system
862.1040 1
JKL
acid, delta-aminolevulinic, ion-exchange columns w ... Delta-aminolevulinic acid test system
862.1060 1
CIZ
radioimmunoassay, androstenedione Androstenedione test system
862.1075 1
CIY
radioimmunoassay, androsterone Androsterone test system
862.1080 1
JMA
acid, ascorbic, 2,4-dinitrophenylhydrazine (spectr ... Ascorbic acid test system
862.1095 1
JJB
azo-dyes, colorimetric, bilirubin & its conjugates ... Urinary bilirubin and its conjugates (no...
862.1115 1
JKP
chromium-51, blood volume Blood volume test system
862.1130 1
JKD
radioimmunoassay, c-peptides of proinsulin C-peptides of proinsulin test system
862.1135 1
CHQ
chromatographic/fluorometric method, catecholamine ... Catecholamines (total) test system
862.1165 1
CHT
electrophoretic method, catecholamines Catecholamines (total) test system
862.1165 1
CGO
lieberman-burchard/abell-kendall, colorimetric, ch ... Cholesterol (total) test system
862.1175 1
CHD
acid, ferric ion-sulfuric, cholesterol Cholesterol (total) test system
862.1175 1
CHH
enzymatic esterase--oxidase, cholesterol Cholesterol (total) test system
862.1175 1
JKW
n-acetyl-l-tyrosine ethyl ester (u.v.), chymotryps ... Chymotrypsin test system
862.1180 1
JKX
n-benzoyl-l-tyrosine ethyl ester (u.v.), chymotryp ... Chymotrypsin test system
862.1180 1
JKB
radioimmunoassay, compound s (11-deoxycortisol) Compound S (11-deoxycortisol) test syste...
862.1185 1
JKY
oxalydihydrazide (spectroscopic), copper Copper test system
862.1190 1
JKZ
diethyldithiocarbamate (colorimetric), copper Copper test system
862.1190 1
CHE
radioimmunoassay, corticoids Corticoids test system
862.1195 1
CHA
radioimmunoassay, corticosterone Corticosterone test system
862.1200 1
JLA
conversion to creatinine, creatine Creatine test system
862.1210 1
JLB
atp and creatine kinase (enzymatic), creatine Creatine test system
862.1210 1
JLC
nitroprusside reaction (qualitative, urine), cysti ... Cystine test system
862.1240 1
JLD
chromatographic, cystine Cystine test system
862.1240 1
JKC
radioimmunoassay, dehydroepiandrosterone (free and ... Dehydroepiandrosterone (free and sulfate...
862.1245 1
JLE
radioimmunoassay, desoxycorticosterone Desoxycorticosterone test system
862.1250 1
JLY
phosphoglycerate mutase (colorimetric), 2,3-diphos ... 2,3-Diphosphoglyceric acid test system
862.1255 1
JLZ
nadh, phosphoglycerate mutase, atp (u.v.) 2,3-diph ... 2,3-Diphosphoglyceric acid test system
862.1255 1
CHP
radioimmunoassay, estradiol Estradiol test system
862.1260 1
NDR
enzyme immunoassay, inhibin-a Estradiol test system
862.1260 1
CGI
radioimmunoassay, estriol Estriol test system
862.1265 1
CHM
radioimmunoassay, total estrogens in pregnancy Estrogens (total, in pregnancy) test sys...
862.1270 1
JMD
radioimmunoassay, total estrogens, nonpregnancy Estrogens (total, nonpregnancy) test sys...
862.1275 1
CGF
radioimmunoassay, estrone Estrone test system
862.1280 1
JLF
radioimmunoassay, etiocholanolone Etiocholanolone test system
862.1285 1
JLG
conversion to ferric hydroxymates (colorimetric), ... Fatty acids test system
862.1290 1
JLH
titrimetric, fatty acids Fatty acids test system
862.1290 1
CGJ
radioimmunoassay, follicle-stimulating hormone Follicle-stimulating hormone test system...
862.1300 1
NGA
test, follicle stimulating hormone (fsh), over the ... Follicle-stimulating hormone test system...
862.1300 1
JLI
tetrahydrofolate, enzymatic (u.v.), formiminogluta ... Formiminoglutamic acid (FIGLU) test syst...
862.1305 1
JLK
sodium hydroxide and phenol red (titrimetric), gas ... Gastric acidity test system
862.1320 1
JLL
tubeless analysis, gastric acidity Gastric acidity test system
862.1320 1
CGC
radioimmunoassay, gastrin Gastrin test system
862.1325 1
CGH
electrophoretic, globulin Globulin test system
862.1330 1
JGC
tryptophan measurement (colorimetric), globulin Globulin test system
862.1330 1

*   The maximium 1000 devices meeting your search criteria returned. Please narrow your search.
 
 
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