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
1801–1825 of 11199
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 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
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
Cleared Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · Andon Health Co, Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 269d
Cleared Jul 21, 2008
RAMP NT-PROBNP ASSAY
K063662 · Response Biomedical Corp.
NBC · Test, Natriuretic Peptide · 591d
Cleared Jul 18, 2008
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · Wako Chemicals USA, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 183d
Cleared Jul 17, 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc.
CFR · Hexokinase, Glucose · 182d
Cleared Jul 16, 2008
DIAZYME APOLIPOPROTEIN A-1 ASSAY
K072977 · General Atomics
MSJ · Apolipoproteins · 268d
Cleared Jul 15, 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K081389 · Roche Diagnostics
NBW · System, Test, Blood Glucose, Over The Counter · 57d
Cleared Jul 14, 2008
S40 CLINICAL ANALYZER, S TEST ALB
K072143 · Alfa Wassermann Diagnostic Technologies, Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 347d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · Siemens Healthcare Diagnostics
JIT · Calibrator, Secondary · 20d
Cleared Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
K081643 · Siemens Healthcare Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 21d
Cleared Jul 03, 2008
IDEAL LIFE POD (MODEL ILP 0001)
K080538 · Ideal Life, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 128d
Cleared Jul 02, 2008
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
K081609 · Taidoc Technology Corporation
CGA · Glucose Oxidase, Glucose · 23d
Cleared Jul 02, 2008
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · Siemens Healthcare Diagnostics
JHM · Colorimetric Method, Lipoproteins · 55d
Cleared Jun 30, 2008
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc.
JGS · Electrode, Ion Specific, Sodium · 41d
Cleared Jun 30, 2008
S-TEST CREATININE (CRE)
K080073 · Alfa Wassermann, Inc.
JFY · Enzymatic Method, Creatinine · 171d
Cleared Jun 30, 2008
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
K072854 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 269d
Cleared Jun 27, 2008
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
K080283 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 144d
Cleared Jun 27, 2008
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · Siemens Medical Solutions Diagnostics
MQM · Bilirubin (total And Unbound) In The Neonate Test System · 193d
Cleared Jun 26, 2008
S-TEST C02
K073223 · Alfa Wassermann Diagnostic Technologies, Inc.
KHS · Enzymatic, Carbon-dioxide · 224d

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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