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
11244 Chemistry devices
Cleared
May 02, 1994
LIQUID AST (SGOT)REAGENT SET
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
54d
Cleared
Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
MMI
Immunoassay Method, Troponin Subunit
603d
Cleared
Apr 26, 1994
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
251d
Cleared
Apr 26, 1994
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
JIF
Enzymatic Method, Ammonia
193d
Cleared
Apr 26, 1994
EML 100
JGS
Electrode, Ion Specific, Sodium
181d
Cleared
Apr 26, 1994
MULTICHECK(TM)
JJS
Controls For Blood-gases, (assayed And Unassayed)
162d
Cleared
Apr 26, 1994
SYNERMED IR 500 CHEMISTRY ANALYZER
JIQ
Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
151d
Cleared
Apr 26, 1994
IMMULITE DHEA-S04
JKC
Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
145d
Cleared
Apr 26, 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
CEC
Radioimmunoassay, Free Thyroxine
83d
Cleared
Apr 26, 1994
CEDIA T4 MAB ASSAY
KLI
Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
50d
Cleared
Apr 26, 1994
SYNERMED ISE REAGENTS
JGS
Electrode, Ion Specific, Sodium
35d
Cleared
Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
KNK
Acid, Uric, Uricase (colorimetric)
322d
Cleared
Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
227d
Cleared
Apr 21, 1994
SYNERMEDIR CAL I AND SYNERMED IR CAL II
JIX
Calibrator, Multi-analyte Mixture
72d
Cleared
Apr 20, 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
98d
Cleared
Apr 20, 1994
SYNERMED TOTAL BILIRUBIN REAGENT KIT
CIG
Diazo Colorimetry, Bilirubin
71d
Cleared
Apr 15, 1994
ONE STEP PREGNANCY TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
119d
Cleared
Apr 13, 1994
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
JQW
Station, Pipetting And Diluting, For Clinical Use
231d
Cleared
Apr 08, 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
JHI
Visual, Pregnancy Hcg, Prescription Use
106d
Cleared
Apr 08, 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
JHI
Visual, Pregnancy Hcg, Prescription Use
106d
Cleared
Apr 06, 1994
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
JJG
Analyzer, Chemistry, Centrifugal, For Clinical Use
194d
Cleared
Apr 06, 1994
URINARY/CEREBROSPINAL FLUID PROTEIN
CEK
Biuret (colorimetric), Total Protein
180d
Cleared
Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
161d
Cleared
Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
CEP
Radioimmunoassay, Luteinizing Hormone
58d
Cleared
Apr 05, 1994
SYNERMED ISE REAGENTS
JGS
Electrode, Ion Specific, Sodium
82d
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