CFR

Product Code: CFR


Products Classified as CFR

289Hexokinase, GlucoseGlucose Test System.

Total Product Life Cycle (TPLC) Devices

289Hexokinase, GlucoseGlucose Test System.

FDA Consensus Standards

Hexokinase, Glucose [32368]21 CFR §862.1345 🔎
Hexokinase, Glucose [35909]21 CFR §862.1345 🔎
Hexokinase, Glucose [35812]21 CFR §862.1345 🔎

Pre-market Notifications for CFR

K220134Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche Diagnostics
K191899Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated SolutionsRoche Diagnostics
K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories
K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I And ELITROL IIELITechGroup
K151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodDiatron US, Inc.
K131189UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)BECKMAN COULTER, INC.
K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULEALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K120681ADVIA CHEMISTRY GLUH_3 REAGENTSSiemens Healthcare Diagnostics Inc.
K120369HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)HITACHI CHEMICAL DIAGNOSTICS, INC.
K113131LIASYS 450AMS
K112377BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K103788PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTHORIBA ABX SAS
K103531PRESTIGE 24I; BIOLIS 24I; MGC 240TOKYO BOEKI MEDISYS INC.
K101854ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429SIEMENS HEALTHCARE DIAGNOSTICS
K092603COBAS INTEGRA GLUCOSE HK GEN 3 ASSAYRoche Diagnostics

Global Unique Device Identification Database

00380740135454HEXOKINASE, GLUCOSE
00380740135447HEXOKINASE, GLUCOSE
00380740006013HEXOKINASE, GLUCOSE
00380740006006HEXOKINASE, GLUCOSE
00630414596488HEXOKINASE, GLUCOSE
00630414561899HEXOKINASE, GLUCOSE
00630414526812HEXOKINASE, GLUCOSE
00628063400539HEXOKINASE, GLUCOSE
00628063400522HEXOKINASE, GLUCOSE
00628063400515HEXOKINASE, GLUCOSE
00657498001615Hexokinase, Glucose
00657498000809Hexokinase, Glucose
00812137011985Hexokinase, Glucose
00811727015020Hexokinase, Glucose
00811727011183Hexokinase, Glucose

Maude Adverse Events

GLUCOSEABBOTT MANUFACTURING INC2019-11-04
GLUCOSEABBOTT MANUFACTURING INC2019-10-15
GLUCOSEABBOTT MANUFACTURING INC2019-10-08
CLINICAL CHEMISTRY GLUCOSEABBOTT GERMANY2019-08-20
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2019-07-12
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2019-05-30
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2019-03-22
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2019-02-15
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2019-02-07
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2019-01-15
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2018-12-19
CLINICAL CHEMISTRY GLUCOSEABBOTT MANUFACTURING INC2018-11-20
GLUC2 GLUCOSE HKROCHE DIAGNOSTICS2018-11-07
CLINICAL CHEMISTRY GLUCOSEABBOTT MANUFACTURING INC2018-10-30
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2018-09-12
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2018-06-05
GLUCOSEBECKMAN COULTER2018-05-17
CLINICAL CHEMISTRY GLUCOSEABBOTT MANUFACTURING INC2018-05-01
DNOTE CORE LICENSESIEMENS HEALTHCARE DIAGNOSTICS2018-04-13
CLINICAL CHEMISTRY GLUCOSEABBOTT LABORATORIES2018-04-06
CLINICAL CHEMISTRY GLUCOSEABBOTT MANUFACTURING INC2017-12-01
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2017-11-30
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-11-09
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-11-09
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-11-02
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-11-02
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-10-30
VITROS 5600 INTEGRATED SYSTEMORTHO-CLINICAL DIAGNOSTICS2017-10-30
COBAS INTEGRA 400 PLUSROCHE DIAGNOSTICS2017-10-27
ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-23
GLUC3 GLUCOSE HK GEN.3ROCHE DIAGNOSTICS2017-10-23
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-20
ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-13
ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-13
ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-13
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-12
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-12
ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-11
COBAS 8000 C 702 MODULEROCHE DIAGNOSTICS2017-10-11
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-11
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-09
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-09
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-05
DIMENSION EXL 200SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-05
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2017-09-22
COBAS INTEGRA 400 PLUSROCHE DIAGNOSTICS2017-09-15
DIMENSION EXL WITH LMSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-09-14
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-09-13
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-09-13
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-09-13

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