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CFR — Hexokinase, Glucose Class II

FDA Device Classification

Classification Details

Product Code
CFR
Device Class
Class II
Regulation Number
862.1345
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253490roche diagnosticsGlucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsFebruary 12, 2026
K252357abbott irelandGlucose2October 24, 2025
K220134roche diagnosticscobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONSeptember 16, 2022
K191899roche diagnosticsGlucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated sAugust 16, 2019
K170316abbott laboratoriesALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMOctober 19, 2017
K153644elitechgroupELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITeSeptember 7, 2016
K151487diatron u.sDiatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose HeJanuary 14, 2016
K131189beckman coulterUNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)April 17, 2014
K123018alfa wassermann diagnostic technologiesACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECApril 23, 2013
K120681siemens healthcare diagnosticsADVIA CHEMISTRY GLUH_3 REAGENTSMay 15, 2012
K120369hitachi chemical diagnosticsHITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)May 10, 2012
K112377shenzhen mindray bio-medical electronics coBS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERMarch 23, 2012
K113131amsLIASYS 450March 8, 2012
K103531tokyo boeki medisysPRESTIGE 24I; BIOLIS 24I; MGC 240December 1, 2011
K103788horiba abxPENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTNovember 8, 2011
K101854siemens healthcare diagnosticsADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429March 7, 2011
K092603roche diagnosticsCOBAS INTEGRA GLUCOSE HK GEN 3 ASSAYDecember 4, 2009
K090703polymedcoPOLY-CHEM 90 GLUCOSEOctober 20, 2009
K092506medicaEASYRA GLU-H REAGENT, MODEL 10200September 16, 2009
K081276horiba abxABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HSeptember 12, 2008