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
1776–1800 of 13257
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 11, 2009
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
K082811 · Urit Medical Electronic Co., Ltd.
JIO · Blood, Occult, Colorimetric, In Urine · 352d
Cleared Sep 09, 2009
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K091544 · Alfa Wassermann, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 105d
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 04, 2009
UCP HOME DRUG SCREENING TESTS
K091588 · Ucp Biosciences, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 94d
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 Sep 02, 2009
WIENER LAB. URINE STRIP 10 AND 11
K083724 · Wiener Laboratorios Saic
JIO · Blood, Occult, Colorimetric, In Urine · 261d
Cleared Aug 31, 2009
VS-SENSE TEST
K091287 · Common Sense , Ltd.
CEN · Dye-indicator, Ph (urinary, Non-quantitative) · 122d
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 26, 2009
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS
K091820 · Bayer Healthcare
NBW · System, Test, Blood Glucose, Over The Counter · 69d
Cleared Aug 25, 2009
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
K091292 · Becton, Dickinson and Company (BD)
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 113d
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 17, 2009
PATHFAST CK-MB-II, PATHFAST MYO-II
K081360 · Mitsubishi Kagaku Iatron
JHX · Fluorometric Method, Cpk Or Isoenzymes · 459d
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 Aug 14, 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
K090332 · Arkray Factory USA, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 185d
Cleared Aug 06, 2009
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
K091460 · American Biological Technologies, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 80d

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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 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 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