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
11275 Chemistry devices
7501–7525 of 11275
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · Medica Corp.
JGS · Electrode, Ion Specific, Sodium · 91d
Cleared Mar 13, 1987
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
K865071 · Immuchem Corp.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 74d
Cleared Mar 13, 1987
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K870025 · American Research Products Co.
KMS · Phenolphthalein Colorimetry, Carbon-dioxide · 67d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · Diagnostic Products Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 60d
Cleared Mar 13, 1987
FAST GLUCOSE
K870631 · Sclavo, Inc.
CGA · Glucose Oxidase, Glucose · 28d
Cleared Mar 13, 1987
FAST URIC ACID
K870632 · Sclavo, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 28d
Cleared Mar 13, 1987
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
K870776 · Reagents Applications, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 15d
Cleared Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · Intersect Systems, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 10d
Cleared Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · Intersect Systems, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 10d
Cleared Mar 12, 1987
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · Beckman Instruments, Inc.
CET · Olive Oil Emulsion (turbidimetric), Lipase · 120d
Cleared Mar 12, 1987
IQ FREE T4 IMMUNOASSAY
K864658 · Bd Becton Dickinson Vacutainer Systems Preanalytic
CEC · Radioimmunoassay, Free Thyroxine · 104d
Cleared Mar 12, 1987
AFFINITY(TM) HTSH IMMUNIT(TM)
K865081 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 72d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 72d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · Hybritech, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 76d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · Leeco Diagnostics, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 46d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · Em Diagnostic Systems, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 35d
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · Hybritech, Inc.
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 32d
Cleared Mar 06, 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · Ciba Corning Diagnostics Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 73d
Cleared Mar 06, 1987
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K870077 · Catachem, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 57d
Cleared Mar 06, 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · Catachem, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 57d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · Em Diagnostic Systems, Inc.
CIC · Cresolphthalein Complexone, Calcium · 51d
Cleared Mar 06, 1987
WAKO(TM) AUTOKIT LDH
K870401 · Wako Chemicals USA, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 32d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · Em Diagnostic Systems, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 31d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · American Diagnostic Corp.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 30d
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · Em Diagnostic Systems, Inc.
JGJ · Photometric Method, Magnesium · 24d

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All categories 11275 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 483 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 305 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 187 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 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