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
11288 Chemistry devices
8426–8450 of 11288
Cleared Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · Advanced Biomedical Methods, Inc.
CIC · Cresolphthalein Complexone, Calcium · 63d
Cleared Jan 03, 1985
RAICHEM PHOSPHORUS REAGENT
K844316 · Reagents Applications, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 48d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · Advanced Biomedical Methods, Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 57d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · Advanced Biomedical Methods, Inc.
CEK · Biuret (colorimetric), Total Protein · 57d
Cleared Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · Advanced Biomedical Methods, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 57d
Cleared Dec 18, 1984
UROPAPER EIKEN GP
K843753 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 7
K843754 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 6B
K843755 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 5
K843756 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN AG
K843757 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN GK
K843758 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN HAG
K843759 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN G
K843760 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 84d
Cleared Dec 14, 1984
CONCEP-7-BHCG (EIA)
K844153 · Leeco Diagnostics, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 51d
Cleared Dec 12, 1984
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc.
KHE · Reagent, Occult Blood · 96d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp.
JIS · Calibrator, Primary · 19d
Cleared Dec 12, 1984
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · Data Medical Associates, Inc.
JQB · Kinetic Method, Gamma-glutamyl Transpeptidase · 8d
Cleared Dec 11, 1984
CORNING 614 NA/K ANALYZER
K843530 · Corning Medical & Scientific
JGS · Electrode, Ion Specific, Sodium · 95d
Cleared Dec 11, 1984
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · Amersham Corp.
CGI · Radioimmunoassay, Estriol · 27d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468 · Sigma Diagnostics, Inc.
JIT · Calibrator, Secondary · 22d
Cleared Dec 11, 1984
REFERRIL CALIBRATORS
K844585 · Instrumentation Laboratory CO
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · Instrumentation Laboratory CO
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 18d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021 · Advanced Biomedical Methods, Inc.
CGZ · Electrode, Ion-specific, Chloride · 56d
Cleared Dec 10, 1984
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
K844164 · Lkb Instruments, Inc.
DII · Columns, Glc · 46d
Cleared Dec 10, 1984
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LGR · Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) · 46d

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All categories 11288 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