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U.S. Department of Health and Human Services

Product Classification
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151 to 200 of 1000 results *
510(K) Exempt Device Class 1
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sort by regulation number [0-9]
sort by regulation number [9-0]
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CFT
radioimmunoassay, prolactin (lactogen) Prolactin (lactogen) test system
862.1625 1
CEF
electrophoretic, protein fractionation Protein (fractionation) test system
862.1630 1
JQJ
densitometeric, protein fractionation Protein (fractionation) test system
862.1630 1
JQK
immunodiffusion, protein fractionation Protein (fractionation) test system
862.1630 1
JIJ
wet ash method, protein-bound iodine Protein-bound iodine test system
862.1640 1
JIK
dry ash method, protein-bound iodine Protein-bound iodine test system
862.1640 1
JIQ
turbidimetric method, protein or albumin (urinary, ... Urinary protein or albumin (nonquantitat...
862.1645 1
JIR
indicator method, protein or albumin (urinary, non ... Urinary protein or albumin (nonquantitat...
862.1645 1
JNJ
phosphoenol pyruvate, adp, nadh, pyruvate kinase Pyruvate kinase test system
862.1650 1
JLT
acid, pyruvic, enzymatic (u.v.) Pyruvic acid test system
862.1655 1
JJR
electrolyte controls (assayed and unassayed) Quality control material (assayed and un...
862.1660 1
JJS
controls for blood-gases, (assayed and unassayed) Quality control material (assayed and un...
862.1660 1
JJT
enzyme controls (assayed and unassayed) Quality control material (assayed and un...
862.1660 1
JJW
urinalysis controls (assayed and unassayed) Quality control material (assayed and un...
862.1660 1
JJX
single (specified) analyte controls (assayed and u ... Quality control material (assayed and un...
862.1660 1
JJY
multi-analyte controls, all kinds (assayed) Quality control material (assayed and un...
862.1660 1
LCH
tonometer (calibration and q.c. of blood-gas instr ... Quality control material (assayed and un...
862.1660 1
OHQ
multi-analyte controls unassayed Quality control material (assayed and un...
862.1660 1
OLD
internal polymerase chain reaction control, not ... Quality control material (assayed and un...
862.1660 1
MJX
kit, serological, positive control Quality control material (assayed and un...
862.1660 1
MJY
kit, serological, negative control Quality control material (assayed and un...
862.1660 1
MJZ
kit, direct antigen, positive control Quality control material (assayed and un...
862.1660 1
MKA
kit, direct antigen, negative control Quality control material (assayed and un...
862.1660 1
JNK
beta-d-fructose & nadh oxidation (u.v.), sorbitol ... Sorbitol dehydrogenase test system
862.1670 1
CDT
lipase hydrolysis/glycerol kinase enzyme, triglyce ... Triglyceride test system
862.1705 1
CEA
tlc chromatographic separation triglycerides Triglyceride test system
862.1705 1
JGW
fluorometric method, triglycerides Triglyceride test system
862.1705 1
JGX
turbidimetric method, triglycerides Triglyceride test system
862.1705 1
JGY
colorimetric method, triglycerides Triglyceride test system
862.1705 1
JNY
glyceralde-3-phosphate, nadh (enzymatic), triose p ... Triose phosphate isomerase test system
862.1720 1
JNN
p-toluenesulphonyl-l-arginine methyl ester (u.v.), ... Trypsin test system
862.1725 1
JNO
n-benzoyl-l-arginine ethyl ester (u.v.), trypsin Trypsin test system
862.1725 1
CDH
acid, uric, phosphotungstate reduction Uric acid test system
862.1775 1
CDO
acid, uric, uricase (u.v.) Uric acid test system
862.1775 1
JHA
acid, uric, uricase (gasometric) Uric acid test system
862.1775 1
JHC
acid, uric, uricase (oxygen rate) Uric acid test system
862.1775 1
KNK
acid, uric, uricase (colorimetric) Uric acid test system
862.1775 1
LFQ
acid, uric, acid reduction of ferric ion Uric acid test system
862.1775 1
JNP
infrared spectroscopy measurement, urinary calculi ... Urinary calculi (stones) test system
862.1780 1
JNQ
qualitative chemical reactions, urinary calculi (s ... Urinary calculi (stones) test system
862.1780 1
CDM
diazonium colorimetry, urobilinogen (urinary, non- ... Urinary urobilinogen (nonquantitative) t...
862.1785 1
JNZ
fluorometric, uroporphyrin Uroporphyrin test system
862.1790 1
JQL
spectrophotometric, uroporphyrin Uroporphyrin test system
862.1790 1
CDF
acid, vanilmandelic, diazo, p-nitroaniline/vanilli ... Vanilmandelic acid test system
862.1795 1
CDK
acid, vanilmandelic, electrophoretic separation Vanilmandelic acid test system
862.1795 1
JOA
acid, trifluoroacetic, vitamin a, hexane extractio ... Vitamin A test system
862.1805 1
JOB
hexane extraction, fluorescence, vitamin e Vitamin E test system
862.1815 1
JOC
colorimetric, xylose Xylose test system
862.1820 1
JQM
p-bromoaniline, xylose Xylose test system
862.1820 1
NRH
system, breath measurement Xylose test system
862.1820 1

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