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
181d
Avg (2y)
1976
Since
11215 Chemistry devices
2901–2925 of 11215
Cleared Oct 09, 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · Becton, Dickinson & CO
NBW · System, Test, Blood Glucose, Over The Counter · 65d
Cleared Oct 09, 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · Becton, Dickinson & CO
CGA · Glucose Oxidase, Glucose · 65d
Cleared Oct 09, 2002
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472 · Nichols Institute Diagnostics
CEW · Radioimmunoassay, Parathyroid Hormone · 75d
Cleared Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · Princeton BioMeditech Corp.
MMI · Immunoassay Method, Troponin Subunit · 34d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · Beckman Coulter, Inc.
JGS · Electrode, Ion Specific, Sodium · 22d
Cleared Oct 02, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
K022936 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Oct 02, 2002
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
K022885 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 33d
Cleared Oct 02, 2002
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE
K022867 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 35d
Cleared Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
K022455 · Helena Laboratories
CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes · 67d
Cleared Sep 30, 2002
LDL CHOLESTEROL (AUTOMATED)
K022519 · Jas Diagnostics, Inc.
JHM · Colorimetric Method, Lipoproteins · 62d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901 · Ortho-Clinical Diagnostics
JIS · Calibrator, Primary · 24d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851 · Quidel Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 31d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 116d
Cleared Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · Polymer Technology Systems, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 21d
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · Hemagen Diagnostics, Inc.
MRR · System, Test, Low Density, Lipoprotein · 27d
Cleared Sep 17, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758 · Cliniqa Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386 · Arkray, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 57d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 57d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 27d
Cleared Sep 11, 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · Becton, Dickinson & CO
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 12d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 70d
Cleared Sep 10, 2002
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
K021334 · Wiener Laboratories Saic
CJY · Azo Dye, Calcium · 137d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
K022182 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 68d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp.
JFT · Fluorometric, Cortisol · 145d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 65d

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All categories 11215 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 461 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 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 176 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