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
1801–1825 of 13257
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
K090358 · Abbott Laboratories, Inc.
LEG · Enzyme Immunoassay, Valproic Acid · 175d
Cleared Aug 03, 2009
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
K091333 · Alfa Wassermann, Inc.
MRR · System, Test, Low Density, Lipoprotein · 89d
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 23, 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · Lifeloc Technologies, Inc.
DJZ · Devices, Breath Trapping, Alcohol · 122d
Cleared Jul 17, 2009
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
K091296 · Polymap Wireless
NBW · System, Test, Blood Glucose, Over The Counter · 74d
Cleared Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734 · Medica Corp.
MRR · System, Test, Low Density, Lipoprotein · 120d
Cleared Jul 14, 2009
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
K090389 · Bestgen Biotech Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 147d
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
Cleared Jul 09, 2009
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130 · Perkinelmer, Inc.
NQL · System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry · 259d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541 · Roche Diagnostics
JJY · Multi-analyte Controls, All Kinds (assayed) · 122d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 59d
Cleared Jun 24, 2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K090109 · Epocal, Inc.
CGA · Glucose Oxidase, Glucose · 160d
Cleared Jun 23, 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090404 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 126d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
K082340 · Roche Diagnostics Corp.
CGN · Acid, Folic, Radioimmunoassay · 308d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
K090939 · Roche Diagnostics
DKB · Calibrators, Drug Mixture · 76d
Cleared Jun 16, 2009
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · Turklab Medical Devices, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 419d
Cleared Jun 11, 2009
MODIFICATION TO AVIE A1C TEST SYSTEM
K091400 · Mec Dynamics Corp
LCP · Assay, Glycosylated Hemoglobin · 30d
Cleared Jun 08, 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · Church & Dwight Co., Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 175d
Cleared Jun 05, 2009
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
K090283 · Genchem, Inc.
JIX · Calibrator, Multi-analyte Mixture · 120d
Cleared Jun 04, 2009
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
K090629 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 87d
Cleared Jun 03, 2009
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
K090737 · Bio-Rad Laboratories, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 75d
Cleared May 27, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
K090943 · American Biological Technologies, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 54d

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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