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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
1851–1875 of 13257
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
PATHFAST HSCRP
K083412 · Mitsubishi Kagaku Iatron
DCN · System, Test, C-reactive Protein · 111d
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 27, 2009
GLUCODR PLUS SYSTEM, MODEL AGM-3000
K082328 · All Medicus Co., Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 197d
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
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
K080853 · Genexel-Sein, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 331d
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
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
K080636 · Hubdic Co., Ltd.
CGA · Glucose Oxidase, Glucose · 344d
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 03, 2009
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
K083265 · Agamatrix, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 90d
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 27, 2009
APIERON INSIGHT ENO SYSTEM
K083617 · Apieron, Inc.
MXA · System, Test, Breath Nitric Oxide · 50d
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

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162