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510(k) K253490

Device
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
Applicant
Roche Diagnostics
510(k) number
K253490
Product code
CFR
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-12
Date received
2025-10-24
Regulation
862.1345
Classification name
Hexokinase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Noel Mencias
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CFR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252357Glucose2Abbott Ireland2025-10-24
K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche Diagnostics2022-09-16
K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics2019-08-16
K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories2017-10-19
K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup2016-09-07
K151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodDiatron U.S., Inc.2016-01-14
K131189UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)Beckman Coulter, Inc.2014-04-17
K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULEAlfa Wassermann Diagnostic Technologies, Inc.2013-04-23
K120681ADVIA CHEMISTRY GLUH_3 REAGENTSSiemens Healthcare Diagnostics, Inc.2012-05-15
K120369HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)Hitachi Chemical Diagnostics, Inc.2012-05-10
K112377BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-03-23
K113131LIASYS 450Ams2012-03-08
K103531PRESTIGE 24I; BIOLIS 24I; MGC 240Tokyo Boeki Medisys, Inc.2011-12-01
K103788PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTHORIBA ABX SAS2011-11-08
K101854ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429Siemens Healthcare Diagnostics2011-03-07