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
11197 Chemistry devices
1726–1750 of 11197
Cleared Mar 24, 2009
BETACHEK GLUCOSE TEST
K062187 · National Diagnostic Products
NBW · System, Test, Blood Glucose, Over The Counter · 966d
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 84d
Cleared Mar 13, 2009
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404 · Medica Corp.
JIX · Calibrator, Multi-analyte Mixture · 393d
Cleared Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
K083906 · Siemens Healthcare Diagnostics
NDY · Test, Cystatin C · 71d
Cleared Mar 11, 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570 · Taidoc Technology Corporation
CGA · Glucose Oxidase, Glucose · 98d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339 · Siemens Healthcare Diagnostics, Inc.
CIC · Cresolphthalein Complexone, Calcium · 117d
Cleared Feb 27, 2009
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
K083680 · Ortho-Clinical Diagnostics, Inc.
CEM · Electrode, Ion Specific, Potassium · 77d
Cleared Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
K083465 · Siemens Healthcare Diagnostics
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 95d
Cleared Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · Siemens Healthcare Diagnostics
JIT · Calibrator, Secondary · 95d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · Siemens Healthcare Diagnostics, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 169d
Cleared Feb 20, 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · Siemens Healthcare Diagnostics
JIX · Calibrator, Multi-analyte Mixture · 78d
Cleared Feb 20, 2009
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · U. S. Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 199d
Cleared Feb 20, 2009
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
K080874 · Medica Corp.
CIX · Bromcresol Green Dye-binding, Albumin · 326d
Cleared Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481 · Beckman Coulter, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 364d
Cleared Feb 13, 2009
MEDTOXSCAN
K080635 · Medtox Diagnostics, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 344d
Cleared Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
K083468 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 78d
Cleared Feb 06, 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · Diamond Diagnostics, Inc.
JGS · Electrode, Ion Specific, Sodium · 163d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · Siemens Healthcare Diagnostics, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 80d
Cleared Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc.
DCN · System, Test, C-reactive Protein · 108d
Cleared Jan 30, 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
K082482 · Taidoc Technology Corporation
CGA · Glucose Oxidase, Glucose · 155d
Cleared Jan 23, 2009
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
K081796 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 212d
Cleared Jan 16, 2009
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
K083099 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 88d
Cleared Jan 16, 2009
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
K082521 · Card Guard Scientific Survival , Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 136d
Cleared Jan 16, 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · Cliniqa Corporation
JJW · Urinalysis Controls (assayed And Unassayed) · 197d
Cleared Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · Roche Diagnostics
CIG · Diazo Colorimetry, Bilirubin · 263d

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All categories 11197 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 298 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