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
1926–1950 of 13257
Cleared Aug 29, 2008
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
K081731 · Siemens Healthcare Diagnostics
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 71d
Cleared Aug 26, 2008
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
K081726 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 69d
Not Cleared Aug 26, 2008
ALLOMAP MOLECULAR EXPRESSION TESTING
DEN080007 · Xdx
OJQ · Cardiac Allograft Gene Expression Profiling Test System · 11d
Cleared Aug 22, 2008
MSC LIPID CONTROL
K082067 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 31d
Cleared Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
K080643 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 169d
Cleared Aug 21, 2008
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
K082099 · Ortho-Clinical Diagnostics, Inc.
CGZ · Electrode, Ion-specific, Chloride · 27d
Cleared Aug 20, 2008
GENTIAN CYSTATIN C IMMUNOASSAY
K081875 · Gentian AS
NDY · Test, Cystatin C · 49d
Cleared Aug 19, 2008
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
K080872 · Amedica Biotech, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 141d
Cleared Aug 19, 2008
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
K080641 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 166d
Cleared Aug 13, 2008
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
K080710 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 153d
Cleared Aug 08, 2008
FDTX GLUCOSE CONTROL SOLUTION
K081915 · Fujirebio Diagnostics Texas, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 36d
Cleared Aug 08, 2008
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
K080273 · Fujirebio Diagnostics Texas, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 189d
Cleared Aug 08, 2008
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
K080167 · Siemens Healthcare Diagnostics
CEC · Radioimmunoassay, Free Thyroxine · 198d
Cleared Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
K071649 · Wallac OY
JIA · Enzymatic Methods, Galactose · 416d
Cleared Aug 05, 2008
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
K081957 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 27d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · Siemens Healthcare Diagnostics, Inc.
JIT · Calibrator, Secondary · 84d
Cleared Jul 31, 2008
ABL 80 CO-OX SYSTEM
K080370 · Sendx Medical, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 170d
Cleared Jul 30, 2008
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
K080995 · Affymetrix, Inc.
NSU · Instrumentation For Clinical Multiplex Test Systems · 114d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
K081294 · Siemens Healthcare Diagnostics, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 83d
Cleared Jul 25, 2008
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K081714 · Taidoc Technology Corporation
CGA · Glucose Oxidase, Glucose · 37d
Cleared Jul 25, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 67d
Cleared Jul 25, 2008
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848 · Q3 Innovations, LLC
DJZ · Devices, Breath Trapping, Alcohol · 121d
Cleared Jul 25, 2008
LIASYS WITH MODELS LIASYS
K080468 · Ams S.R.L. Analyzer Medical System
CFR · Hexokinase, Glucose · 155d
Cleared Jul 23, 2008
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
K063841 · Liposcience
MRR · System, Test, Low Density, Lipoprotein · 575d
Cleared Jul 21, 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
K081229 · Smiths Medical Asd, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 82d

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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