FDA Review Panel · CH

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
11326 Chemistry devices
10501–10525 of 11326
Cleared Sep 27, 1979
URIC ACID REAGENT
K791754 · Gilford Diagnostics
KNK · Acid, Uric, Uricase (colorimetric) · 22d
Cleared Sep 27, 1979
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760 · Fisher Scientific Co., LLC
CFR · Hexokinase, Glucose · 22d
Cleared Sep 24, 1979
ORTHO TSH RIA KIT
K791301 · Ortho Diagnostics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 70d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · Coulter Electronics, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 34d
Cleared Sep 24, 1979
SGPT REAGENT SET MODIFICATION
K791641 · American Monitor Corp.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 34d
Cleared Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
K791669 · Macomb Chemical Co.
CGA · Glucose Oxidase, Glucose · 27d
Cleared Sep 24, 1979
NADH OXIDATION, AST/SGOT
K791679 · American Monitor Corp.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 27d
Cleared Sep 24, 1979
CONTRO I
K791695 · Hi Chem, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 55d
Cleared Sep 24, 1979
CONTRO II
K791696 · Hi Chem, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 55d
Cleared Sep 24, 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · Gilford Diagnostics
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 27d
Cleared Sep 19, 1979
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
K791712 · Ventrex Laboratories, Inc.
KQN · Radioassay, Angiotensin Converting Enzyme · 50d
Cleared Sep 17, 1979
VENTRE/SEP T4 TEST SET
K791368 · Ventrex Laboratories, Inc.
CDX · Radioimmunoassay, Total Thyroxine · 54d
Cleared Sep 17, 1979
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp.
CEP · Radioimmunoassay, Luteinizing Hormone · 48d
Cleared Sep 17, 1979
GELMAN LIPOPROTEIN FRS SET. P/N 51213
K791606 · Gelman Sciences, Inc.
JHO · Electrophoretic Separation, Lipoproteins · 28d
Cleared Sep 17, 1979
NORMAL CONTROL
K791654 · Electrophoresis Corp. of America
JJY · Multi-analyte Controls, All Kinds (assayed) · 27d
Cleared Sep 17, 1979
CPK ISOENZYME REAGENT
K791655 · Electrophoresis Corp. of America
JHY · Colorimetric Method, Cpk Or Isoenzymes · 27d
Cleared Sep 17, 1979
ENZYME STABILIZING REAGENT (ESR)
K791656 · Electrophoresis Corp. of America
CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes · 27d
Cleared Sep 17, 1979
LDH ISOENZYME REAGENT
K791657 · Electrophoresis Corp. of America
CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes · 27d
Cleared Sep 17, 1979
GLUCOSE REAGENT
K791685 · Hi Chem, Inc.
CGA · Glucose Oxidase, Glucose · 48d
Cleared Sep 17, 1979
CO2 CUP REAGENT
K791686 · Hi Chem, Inc.
JFL · Ph Rate Measurement, Carbon-dioxide · 48d
Cleared Sep 17, 1979
CO2 REFERENCE REAGENT
K791687 · Hi Chem, Inc.
JFL · Ph Rate Measurement, Carbon-dioxide · 48d
Cleared Sep 17, 1979
ALKALINE BUFFER
K791688 · Hi Chem, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 48d
Cleared Sep 17, 1979
PICRIC SOLUTION
K791689 · Hi Chem, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 48d
Cleared Sep 17, 1979
CHOLORDE REAGENT
K791690 · Hi Chem, Inc.
JFS · Coulometric, Chloride · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM CONDITIONING SOLUTION
K791691 · Hi Chem, Inc.
JGS · Electrode, Ion Specific, Sodium · 48d

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All categories 11326 NBW System, Test, Blood Glucose, Over The Counter 497 JJY Multi-analyte Controls, All Kinds (assayed) 493 JJX Single (specified) Analyte Controls (assayed And Unassayed) 389 CGA Glucose Oxidase, Glucose 311 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 200 JLW Radioimmunoassay, Thyroid-stimulating Hormone 189 CHH Enzymatic Esterase--oxidase, Cholesterol 187 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 177 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 158 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143