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
11263 Chemistry devices
6926–6950 of 11263
Cleared Jul 08, 1988
BIOTROL ALKALINE PHOSPHATASE
K881742 · Biotrol, USA, Inc.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 77d
Cleared Jul 08, 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · Data Medical Associates, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 74d
Cleared Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · Helena Laboratories
JJN · Apparatus, Electrophoresis, For Clinical Use · 67d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · Hichem Diagnostics
JJY · Multi-analyte Controls, All Kinds (assayed) · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · Hichem Diagnostics
JJY · Multi-analyte Controls, All Kinds (assayed) · 92d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories
KXT · Enzyme Immunoassay, Digoxin · 40d
Cleared Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · Diagnostic Systems Laboratories, Inc.
CFL · Radioimmunoassay, Human Growth Hormone · 192d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750 · Nova Biomedical Corp.
JGS · Electrode, Ion Specific, Sodium · 128d
Cleared Jul 01, 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113 · Creative Laboratory Products, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 108d
Cleared Jul 01, 1988
BIOTROL TOTAL PROTEIN H.P.
K882189 · Biotrol, USA, Inc.
CEK · Biuret (colorimetric), Total Protein · 38d
Cleared Jul 01, 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · Terumo Medical Corp.
CHP · Radioimmunoassay, Estradiol · 24d
Cleared Jun 24, 1988
DELFIA ESTRADIOL KIT
K882173 · Pharmacia, Inc.
CHP · Radioimmunoassay, Estradiol · 31d
Cleared Jun 20, 1988
HELENA REP GEL PROCESSOR
K882163 · Helena Laboratories
JJN · Apparatus, Electrophoresis, For Clinical Use · 27d
Cleared Jun 16, 1988
BIOTROL CREATININE H.P. REAGENT
K881856 · Biotrol, USA, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 44d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp.
GKR · System, Hemoglobin, Automated · 141d
Cleared Jun 15, 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · Trace Scientific , Ltd.
KHS · Enzymatic, Carbon-dioxide · 37d
Cleared Jun 10, 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · Reagents Applications, Inc.
CJY · Azo Dye, Calcium · 121d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244 · Trace Scientific , Ltd.
LBR · Ldl & Vldl Precipitation, Hdl · 79d
Cleared Jun 10, 1988
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · Casco Standards
JJR · Electrolyte Controls (assayed And Unassayed) · 45d
Cleared Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · Syva Co.
KHQ · Radioassay, Triiodothyronine Uptake · 38d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 37d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 36d
Cleared Jun 08, 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · Amersham Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 51d
Cleared Jun 08, 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic
CFT · Radioimmunoassay, Prolactin (lactogen) · 43d
Cleared Jun 08, 1988
IMPRES-MB
K881801 · Intl. Immunoassay Laboratories, Inc.
JHW · U.v. Method, Cpk Isoenzymes · 42d

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All categories 11263 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 478 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 305 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 187 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