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
2251–2275 of 13257
Cleared Oct 30, 2006
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
K061234 · Glucoplus, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 181d
Cleared Oct 23, 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916 · Cliniqa Corporation
JJY · Multi-analyte Controls, All Kinds (assayed) · 25d
Cleared Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
K062361 · Innovacon, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 70d
Cleared Oct 18, 2006
AMNIOSTAT-FLM-PG
K061549 · Irvine Scientific Sales Co., Inc.
JHG · Chromatographic Separation, Lecithin/sphingomyelin Ratio · 135d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668 · Aalto Scientific, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 38d
Cleared Oct 16, 2006
ABL8X7 FLEX
K051968 · Radiometer Medical Aps
CGL · Electrode, Ion Based, Enzymatic, Creatinine · 453d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 14d
Cleared Oct 13, 2006
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
K062808 · Catch Incorporated
LPS · Urinary Homocystine (nonquantitative) Test System · 24d
Cleared Oct 10, 2006
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
K062829 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 20d
Cleared Oct 05, 2006
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575 · Olympus America, Inc.
CJY · Azo Dye, Calcium · 120d
Cleared Oct 03, 2006
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · Quantimetrix Corp.
JJT · Enzyme Controls (assayed And Unassayed) · 19d
Cleared Oct 02, 2006
ABX PENTRA AMYLASE CP
K062180 · Horiba Abx
JFJ · Catalytic Methods, Amylase · 63d
Cleared Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · Maine Standards Co.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 35d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · Lin-Zhi International, Inc.
LAF · Gas Chromatography, Methamphetamine · 58d
Cleared Sep 29, 2006
ABX PENTRA 400 : CRP
K061138 · Horiba Abx
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 158d
Cleared Sep 27, 2006
EPOC BLOOD ANALYSIS SYSTEM
K061597 · Epocal, Inc.
JGS · Electrode, Ion Specific, Sodium · 111d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 43d
Cleared Sep 22, 2006
ARCHITECT CORTISOL ASSAY
K062204 · Seradyn, Inc.
JFT · Fluorometric, Cortisol · 52d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO
LPS · Urinary Homocystine (nonquantitative) Test System · 106d
Cleared Sep 22, 2006
SELFCHECK GLUCO
K061528 · Card Guard Scientific Survival , Ltd.
CGA · Glucose Oxidase, Glucose · 112d
Cleared Sep 19, 2006
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM
K062235 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 48d
Cleared Sep 19, 2006
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
K061992 · Eps Bio Technology Corp.
CGA · Glucose Oxidase, Glucose · 68d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · Dade Behring, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 68d
Cleared Sep 15, 2006
PREVU POINT OF CARE SKIN STEROL TEST
K062092 · Premd, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 53d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974 · Instrumentation Laboratory CO
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 65d

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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