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
3201 Chemistry devices
Cleared
Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
CEC
Radioimmunoassay, Free Thyroxine
71d
Cleared
Jul 07, 1997
PRECINORM TDM CONTROLS
DIF
Drug Mixture Control Materials
105d
Cleared
Jun 24, 1997
ABBOTT AXSYM FOLATE
CGN
Acid, Folic, Radioimmunoassay
8d
Cleared
Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
JJY
Multi-analyte Controls, All Kinds (assayed)
12d
Cleared
Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
JJY
Multi-analyte Controls, All Kinds (assayed)
19d
Cleared
Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
24d
Cleared
Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
JJY
Multi-analyte Controls, All Kinds (assayed)
14d
Cleared
Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
CHH
Enzymatic Esterase--oxidase, Cholesterol
47d
Cleared
Jun 04, 1997
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
CHI
Lipase-esterase, Enzymatic, Photometric, Lipase
84d
Cleared
Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
CEF
Electrophoretic, Protein Fractionation
306d
Cleared
May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
JJT
Enzyme Controls (assayed And Unassayed)
13d
Cleared
May 27, 1997
IMMULITE PYRILINKS-D
JMM
Column Chromatography & Color Development, Hydroxyproline
48d
Cleared
May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD
JIX
Calibrator, Multi-analyte Mixture
43d
Cleared
May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
KNK
Acid, Uric, Uricase (colorimetric)
70d
Cleared
May 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
KLI
Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
45d
Cleared
May 16, 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
CDD
Radioassay, Vitamin B12
46d
Cleared
May 09, 1997
WINMAX SOFTWARE SYSTEMS
JJF
Analyzer, Chemistry, Micro, For Clinical Use
140d
Cleared
Apr 21, 1997
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
MSJ
Apolipoproteins
87d
Cleared
Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
16d
Cleared
Mar 24, 1997
AXSYM B12
CDD
Radioassay, Vitamin B12
90d
Cleared
Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
JLS
Radioimmunoassay, Progesterone
111d
Cleared
Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
102d
Cleared
Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
DIF
Drug Mixture Control Materials
14d
Cleared
Mar 10, 1997
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
70d
Cleared
Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
20d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices