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
1951–1975 of 13257
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
Cleared Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142 · Alfa Wassermann Diagnostic Technologies, Inc.
CKF · Phenylphosphate, Alkaline Phosphatase Or Isoenzymes · 329d
Cleared Jun 25, 2008
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · SENTINEL CH. SpA
JIX · Calibrator, Multi-analyte Mixture · 23d
Cleared Jun 24, 2008
S-TEST CA
K072356 · Alfa Wassermann Diagnostic Technologies, Inc.
CJY · Azo Dye, Calcium · 307d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · Alfa Wassermann Diagnostic Technologies, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 327d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · Alfa Wassermann Diagnostic Technologies, Inc.
CFR · Hexokinase, Glucose · 327d
Cleared Jun 23, 2008
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
K081144 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 62d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811 · Roche Diagnostics Corp.
NDY · Test, Cystatin C · 88d

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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