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
191d
Avg (2y)
1976
Since
11199 Chemistry devices
1851–1875 of 11199
Cleared Apr 21, 2008
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
K080501 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 56d
Cleared Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
K073231 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 155d
Cleared Apr 18, 2008
3TEST SUPREME GLUCOSE MONITORING SYSTEM
K072905 · Neuero Engineering, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 190d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp.
LCP · Assay, Glycosylated Hemoglobin · 206d
Cleared Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · Teco Diagnostics
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 221d
Cleared Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · Medica Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 123d
Cleared Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · Wallac OY
CGZ · Electrode, Ion-specific, Chloride · 381d
Cleared Apr 10, 2008
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
K073648 · Apex BioTechnology Corp.
CGA · Glucose Oxidase, Glucose · 106d
Cleared Apr 10, 2008
GBI TSH NEONATAL SCREENING KIT
K072458 · Golden Bridge International, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 223d
Cleared Apr 08, 2008
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
K073492 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 118d
Cleared Apr 04, 2008
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
K063437 · Monobind, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 507d
Cleared Apr 02, 2008
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
K073494 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 112d
Cleared Apr 01, 2008
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 146d
Cleared Mar 26, 2008
MCT-DIABETES
K073699 · Mycare Team, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 86d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp.
DIF · Drug Mixture Control Materials · 60d
Cleared Mar 25, 2008
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
K072441 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 208d
Cleared Mar 21, 2008
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
K072369 · Hmd Biomedical, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 211d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 56d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · Abbott Laboratories
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 289d
Cleared Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · Axis-Shield Diagnostics, Ltd.
LCP · Assay, Glycosylated Hemoglobin · 175d
Cleared Mar 14, 2008
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K073265 · Apieron, Inc.
MXA · System, Test, Breath Nitric Oxide · 115d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K073604 · Dade Behring, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 83d
Cleared Mar 11, 2008
DRAEGER ALCOTEST 6510
K063443 · Drager Safety
DJZ · Devices, Breath Trapping, Alcohol · 483d
Cleared Mar 07, 2008
LUMINEX LX 100/200 INSTRUMENT
K073506 · Luminex Corp.
NSU · Instrumentation For Clinical Multiplex Test Systems · 85d
Cleared Mar 07, 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
K073488 · Diazyme Laboratories
MSJ · Apolipoproteins · 137d

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All categories 11199 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 458 JJX Single (specified) Analyte Controls (assayed And Unassayed) 383 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 247 CIG Diazo Colorimetry, Bilirubin 217 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 175 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