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.
13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11215 Chemistry devices
Cleared
Nov 29, 2002
ELECSYS PROBNP CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
256d
Cleared
Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
23d
Cleared
Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
LCP
Assay, Glycosylated Hemoglobin
169d
Cleared
Nov 25, 2002
BD VACUTAINER SST II PLUS TUBES
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
52d
Cleared
Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
68d
Cleared
Nov 22, 2002
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
JJY
Multi-analyte Controls, All Kinds (assayed)
46d
Cleared
Nov 22, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
95d
Cleared
Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
26d
Cleared
Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
NBC
Test, Natriuretic Peptide
112d
Cleared
Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
55d
Cleared
Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
CHH
Enzymatic Esterase--oxidase, Cholesterol
23d
Cleared
Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
JIX
Calibrator, Multi-analyte Mixture
46d
Cleared
Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
84d
Cleared
Nov 05, 2002
INSTANT-VIEW LH OVULATION PREDICTING TEST
CEP
Radioimmunoassay, Luteinizing Hormone
71d
Cleared
Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
JIS
Calibrator, Primary
85d
Cleared
Nov 01, 2002
WIENER LAB. BILIRRUBINA TOTAL AA
CIG
Diazo Colorimetry, Bilirubin
56d
Cleared
Oct 31, 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
LFR
Glucose Dehydrogenase, Glucose
55d
Cleared
Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
LAF
Gas Chromatography, Methamphetamine
84d
Cleared
Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
MKW
Cyclosporine
29d
Cleared
Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
CGA
Glucose Oxidase, Glucose
29d
Cleared
Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
31d
Cleared
Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
JJY
Multi-analyte Controls, All Kinds (assayed)
17d
Cleared
Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
MKW
Cyclosporine
30d
Cleared
Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
JHY
Colorimetric Method, Cpk Or Isoenzymes
52d
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