FDA 510(k) Chemistry Devices
FDA 510(k) Chemistry Devices - Regulatory Overview
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3210 Chemistry devices
Cleared
Oct 13, 1988
VISION CREATINE KINASE
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
24d
Cleared
Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
54d
Cleared
Sep 13, 1988
IQ HDL CHOLESTEROL
LBR
Ldl & Vldl Precipitation, Hdl
35d
Cleared
Aug 30, 1988
VISTA INSTRUMENT
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
49d
Cleared
Aug 30, 1988
DTR ANALYZER
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
49d
Cleared
Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
JJT
Enzyme Controls (assayed And Unassayed)
54d
Cleared
Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
CFR
Hexokinase, Glucose
64d
Cleared
Aug 08, 1988
IMX CKMB
JHY
Colorimetric Method, Cpk Or Isoenzymes
20d
Cleared
Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
LBT
Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
61d
Cleared
Aug 08, 1988
COTUBE HCG IRMA TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
80d
Cleared
Aug 03, 1988
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
CIG
Diazo Colorimetry, Bilirubin
183d
Cleared
Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
JJY
Multi-analyte Controls, All Kinds (assayed)
30d
Cleared
Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
CGA
Glucose Oxidase, Glucose
67d
Cleared
Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
JJN
Apparatus, Electrophoresis, For Clinical Use
67d
Cleared
Jul 08, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
CEK
Biuret (colorimetric), Total Protein
85d
Cleared
Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
88d
Cleared
Jul 06, 1988
TDX (R) DIGOXIN NXT
KXT
Enzyme Immunoassay, Digoxin
40d
Cleared
Jun 20, 1988
HELENA REP GEL PROCESSOR
JJN
Apparatus, Electrophoresis, For Clinical Use
27d
Cleared
Jun 10, 1988
IQ HDL CHOLESTEROL
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
36d
Cleared
Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
37d
Cleared
Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
KHQ
Radioassay, Triiodothyronine Uptake
38d
Cleared
Jun 08, 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
CFT
Radioimmunoassay, Prolactin (lactogen)
43d
Cleared
Jun 07, 1988
BUN (KINETIC)
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
49d
Cleared
Jun 01, 1988
REP LIPO KIT CAT. NO 3180
JHO
Electrophoretic Separation, Lipoproteins
34d
Cleared
Jun 01, 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
54d
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