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
11307 Chemistry devices
9701–9725 of 11307
Cleared Dec 22, 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · Leeco Diagnostics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 19d
Cleared Dec 22, 1981
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · Diagnostic Products Corp.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 18d
Cleared Dec 22, 1981
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405 · Pointe Scientific, Inc.,
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 15d
Cleared Dec 22, 1981
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · Pointe Scientific, Inc.,
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 15d
Cleared Dec 22, 1981
MULTIWASH
K813426 · Flow Laboratories, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 15d
Cleared Dec 22, 1981
TRIGLYCERIDE CALIBRATORS
K813478 · Gilford Diagnostics
JIS · Calibrator, Primary · 21d
Cleared Dec 22, 1981
PROGESTERONE KIT BY RIA
K813484 · Immuchem Corp.
JLS · Radioimmunoassay, Progesterone · 21d
Cleared Dec 17, 1981
ASTRA REAGENT CONCENTRATE SYSTEM
K812866 · Nobel Scientific Industries, Inc.
CGA · Glucose Oxidase, Glucose · 65d
Cleared Dec 17, 1981
ANDRIA-FSH RIA TEST KIT
K813086 · Intl. Immunoassay Laboratories, Inc.
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 45d
Cleared Dec 17, 1981
ABURIA-CK RIA TEST KIT
K813087 · Intl. Immunoassay Laboratories, Inc.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 45d
Cleared Dec 17, 1981
SECURE FDI TEST KIT
K813216 · Beckman Instruments, Inc.
JHG · Chromatographic Separation, Lecithin/sphingomyelin Ratio · 38d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293 · Ortho Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · Ortho Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · Ortho Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared Dec 17, 1981
MINI-SHAKER
K813318 · Dynatech Corp.
JRQ · Shaker/stirrer · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321 · Ortho Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322 · Ortho Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Dec 10, 1981
BECKMAN SYSTEM E4A
K813160 · Beckman Instruments, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 24d
Cleared Dec 08, 1981
VACUSHIELD TM
K813159 · Gelman Sciences, Inc.
JRL · Unit, Filter, Membrane · 22d
Cleared Dec 08, 1981
Y-GLUTAMYLTRANSFERASE
K813215 · American Monitor Corp.
· 29d
Cleared Dec 03, 1981
CREATININE REAGENT SET
K812834 · Anco Medical Reagents & Assoc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 55d
Cleared Dec 03, 1981
TRIGLYCERIDE REAGENT SET
K812838 · Anco Medical Reagents & Assoc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 55d
Cleared Dec 03, 1981
HDL CHOLESTEROL REAGENT SET
K812839 · Anco Medical Reagents & Assoc.
LBR · Ldl & Vldl Precipitation, Hdl · 55d
Cleared Dec 03, 1981
SERUM IRON REAGENT SET
K812840 · Anco Medical Reagents & Assoc.
JIY · Photometric Method, Iron (non-heme) · 55d
Cleared Dec 03, 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · American Research Products Co.
CGA · Glucose Oxidase, Glucose · 17d

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All categories 11307 NBW System, Test, Blood Glucose, Over The Counter 493 JJY Multi-analyte Controls, All Kinds (assayed) 492 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 309 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 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