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
11196 Chemistry devices
1676–1700 of 11196
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · Siemens Healthcare Diagnostics
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 165d
Cleared Oct 02, 2009
AIA-PACK RBC FOLATE
K091332 · Tosoh Bioscience, Inc.
CGN · Acid, Folic, Radioimmunoassay · 149d
Cleared Oct 02, 2009
EOCENE SYSTEM
K090712 · Infopia Co, Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 198d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · Abaxis, Inc.
JGJ · Photometric Method, Magnesium · 98d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 114d
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
K092051 · Microgenics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 76d
Cleared Sep 18, 2009
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 86d
Cleared Sep 16, 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp.
CFR · Hexokinase, Glucose · 30d
Cleared Sep 09, 2009
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
K090104 · DiaSorin, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 237d
Cleared Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
K092645 · Fujirebio Diagnostics,Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 9d
Cleared Sep 04, 2009
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · Medica Corp.
CIG · Diazo Colorimetry, Bilirubin · 64d
Cleared Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861 · Ortho-Clinical Diagnostics, Inc.
JGS · Electrode, Ion Specific, Sodium · 76d
Cleared Sep 03, 2009
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
K090846 · Perkinelmer, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 157d
Cleared Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867 · Beckman Coulter, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 241d
Cleared Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · Roche Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 338d
Cleared Aug 18, 2009
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
K091481 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 91d
Cleared Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · Beckman Coulter, Inc.
JFY · Enzymatic Method, Creatinine · 59d
Cleared Aug 14, 2009
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
K091455 · Diazyme Laboratories
MZV · Test, System, Potassium, Enzymatic Method · 88d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · Siemens Healthcare Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 119d
Cleared Jul 31, 2009
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 95d
Cleared Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · Axis-Shield Diagnostics, Ltd.
LPS · Urinary Homocystine (nonquantitative) Test System · 270d
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc.
LCP · Assay, Glycosylated Hemoglobin · 132d
Cleared Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734 · Medica Corp.
MRR · System, Test, Low Density, Lipoprotein · 120d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · Beckman Coulter, Inc.
KHS · Enzymatic, Carbon-dioxide · 83d
Cleared Jul 13, 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 168d

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All categories 11196 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 457 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