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
11244 Chemistry devices
5151–5175 of 11244
Cleared Feb 03, 1994
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
K935830 · Ciba Corning Diagnostics Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 58d
Cleared Feb 01, 1994
IL TEST CALCIUM
K931362 · Instrumentation Laboratory CO
CIC · Cresolphthalein Complexone, Calcium · 321d
Cleared Jan 31, 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · Intersect Systems, Inc.
JFJ · Catalytic Methods, Amylase · 231d
Cleared Jan 27, 1994
IMMULITE PAP
K931701 · Diagnostic Products Corp.
JFH · Acid Phosphatase (prostatic), Tartrate Inhibited · 296d
Cleared Jan 27, 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · Medical Analysis Systems, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 99d
Cleared Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181 · Em Diagnostic Systems, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 93d
Cleared Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 241d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607 · Roche Diagnostic Systems, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 241d
Cleared Jan 18, 1994
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
K935018 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 90d
Cleared Jan 18, 1994
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
K935547 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 62d
Cleared Jan 13, 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 444d
Cleared Jan 13, 1994
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
K925464 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 441d
Cleared Jan 13, 1994
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
K930231 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 359d
Cleared Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · Em Diagnostic Systems, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 79d
Cleared Jan 11, 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · Hybritech, Inc.
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 328d
Cleared Jan 11, 1994
N-ASSAY TIA MICROALBUMIN
K934146 · Crestat Diagnostics, Inc.
JIR · Indicator Method, Protein Or Albumin (urinary, Non-quant.) · 140d
Cleared Jan 11, 1994
RELIEF PLUS ONE REAGENT STRIP MODIFICATION
K934892 · Diagnostic Solutions, Inc.
CGA · Glucose Oxidase, Glucose · 113d
Cleared Jan 11, 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · International Technidyne Corp.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 78d
Cleared Jan 11, 1994
IMMULITE PROGESTERONE
K935138 · Diagnostic Products Corp.
JLS · Radioimmunoassay, Progesterone · 75d
Cleared Jan 11, 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463 · Pointe Scientific, Inc.,
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 60d
Cleared Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · Randox Laboratories, Ltd.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 544d
Cleared Jan 10, 1994
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp.
CHP · Radioimmunoassay, Estradiol · 209d
Cleared Jan 10, 1994
ACTIVE ANDROSTANEDIOL GLUCURONIDE
K934751 · Diagnostic Systems Laboratories, Inc.
CIZ · Radioimmunoassay, Androstenedione · 98d
Cleared Jan 03, 1994
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · Sigma Chemical Co.
JFL · Ph Rate Measurement, Carbon-dioxide · 158d
Cleared Jan 03, 1994
860 MEASURMENT SYSTEM
K934907 · Ciba Corning Diagnostics Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 80d

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All categories 11244 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 473 JJX Single (specified) Analyte Controls (assayed And Unassayed) 387 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