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
11239 Chemistry devices
4926–4950 of 11239
Cleared Dec 09, 1994
CALCIUM QVET
K943003 · Prisma Systems
CJJ · Diazo, Alt/sgpt · 169d
Cleared Dec 09, 1994
TOTAL PROTEIN QVET
K943004 · Prisma Systems
CEK · Biuret (colorimetric), Total Protein · 169d
Cleared Dec 09, 1994
POTASSIUM QVET
K943026 · Prisma Systems
CEJ · Tetraphenyl Borate, Colorimetry, Potassium · 165d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc.
JFJ · Catalytic Methods, Amylase · 100d
Cleared Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 77d
Cleared Dec 09, 1994
IMX T3 ASSAY
K944808 · Organon Teknika Corp.
CDP · Radioimmunoassay, Total Triiodothyronine · 71d
Cleared Dec 09, 1994
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315 · Casco Standards
JJY · Multi-analyte Controls, All Kinds (assayed) · 38d
Cleared Dec 09, 1994
CLARIT(TM)
K945353 · Advanced Biomedical Methods, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 50d
Cleared Dec 07, 1994
GGT QVET
K942962 · Prisma Systems
JQB · Kinetic Method, Gamma-glutamyl Transpeptidase · 167d
Cleared Dec 07, 1994
CHLORIDE QVET
K943006 · Prisma Systems
CHJ · Mercuric Thiocyanate, Colorimetry, Chloride · 167d
Cleared Dec 07, 1994
HDL QVET
K943028 · Prisma Systems
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 163d
Cleared Dec 07, 1994
VISUALINE II HCG
K943239 · Sun Biomedical Laboratories, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 154d
Cleared Dec 07, 1994
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
K945322 · Emd Chemicals, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 36d
Cleared Dec 06, 1994
DMA CALCIUM PLUS PROCEDURE
K944255 · Data Medical Associates, Inc.
CJY · Azo Dye, Calcium · 96d
Cleared Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp.
KHS · Enzymatic, Carbon-dioxide · 507d
Cleared Dec 02, 1994
BILIRUBIN(TOTAL) QVET
K942999 · Prisma Systems
CIG · Diazo Colorimetry, Bilirubin · 162d
Cleared Dec 02, 1994
URIC ACID QVET
K943002 · Prisma Systems
KNK · Acid, Uric, Uricase (colorimetric) · 162d
Cleared Dec 02, 1994
IRON QVET
K943029 · Prisma Systems
JIY · Photometric Method, Iron (non-heme) · 158d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · Roche Diagnostic Systems, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 93d
Cleared Dec 02, 1994
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
K944452 · Beckman Instruments, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 81d
Cleared Dec 02, 1994
PHOSPHORUS TEST (PHOS)
K945368 · Emd Chemicals, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 43d
Cleared Nov 30, 1994
PROCHEM CHEMISTRY ANALYZER
K944028 · Prisma Systems
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 105d
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361 · Casco Standards
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 84d
Cleared Nov 28, 1994
ACE CEDIA CORTISOL ASSAY
K943427 · Schiapparelli Biosystems, Inc.
CGR · Radioimmunoassay, Cortisol · 136d
Cleared Nov 28, 1994
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · Instrumentation Laboratory CO
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 126d

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All categories 11239 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 472 JJX Single (specified) Analyte Controls (assayed And Unassayed) 385 CGA Glucose Oxidase, Glucose 302 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 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143