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
11287 Chemistry devices
8126–8150 of 11287
Cleared Nov 26, 1985
TECHNICON RA-500 SYSTEM
K854345 · Technicon Instruments Corp.
JJC · Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use · 29d
Cleared Nov 26, 1985
RAICHEM/K.E
K854540 · Reagents Applications, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 13d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · Clinical Data, Inc.
CGA · Glucose Oxidase, Glucose · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · Clinical Data, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · Clinical Data, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · Clinical Data, Inc.
CIG · Diazo Colorimetry, Bilirubin · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · Clinical Data, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185 · Clinical Data, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187 · Clinical Data, Inc.
CIS · Hydrazone Colorimetry, Ast/sgot · 41d
Cleared Nov 25, 1985
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · Clinical Data, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 41d
Cleared Nov 25, 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · American Monitor Corp.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 27d
Cleared Nov 25, 1985
TDX CORTISOL
K854419 · Abbott Laboratories
JFT · Fluorometric, Cortisol · 21d
Cleared Nov 25, 1985
TDX R OPIATES
K854421 · Abbott Laboratories
DJG · Enzyme Immunoassay, Opiates · 21d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502 · Sigma Diagnostics, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 13d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503 · Sigma Diagnostics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 13d
Cleared Nov 25, 1985
TOTAL PROTEIN
K854553 · American Monitor Corp.
CEK · Biuret (colorimetric), Total Protein · 12d
Cleared Nov 22, 1985
CALCITONIN RIA KIT
K854240 · Diagnostic Systems Laboratories, Inc.
JKR · Radioimmunoassay, Calcitonin · 32d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · Sterling Diagnostics, Inc.
CGA · Glucose Oxidase, Glucose · 25d
Cleared Nov 19, 1985
ES 22
K854243 · Boehringer Mannheim Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 29d
Cleared Nov 19, 1985
MR 700 MICROPLATE READER 012-700-1000
K854303 · Dynatech Laboratories, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 25d
Cleared Nov 12, 1985
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · Diagnostic Products Corp.
JKD · Radioimmunoassay, C-peptides Of Proinsulin · 39d
Cleared Nov 12, 1985
KODAKEKTACHEM DTR MODULE
K854138 · Eastman Kodak Company
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 33d
Cleared Nov 12, 1985
IRON
K854298 · Boehringer Mannheim Corp.
CEM · Electrode, Ion Specific, Potassium · 18d
Cleared Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
K854305 · Coulter Electronics, Inc.
CFM · Bathophenanthroline, Colorimetry, Iron (non-heme) · 18d

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All categories 11287 JJY Multi-analyte Controls, All Kinds (assayed) 492 NBW System, Test, Blood Glucose, Over The Counter 488 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 306 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 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