FDA 510(k) Applications for Medical Device Product Code "CFR"
(Hexokinase, Glucose)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990981 | A.P. TOTAL CARE, INC. | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 | 05/25/1999 |
| K170316 | Abbott Laboratories | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | 10/19/2017 |
| K981185 | ABBOTT LABORATORIES | GLU | 05/07/1998 |
| K060383 | ABBOTT LABORATORIES | GLUCOSE | 05/05/2006 |
| K123018 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | 04/23/2013 |
| K072140 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | 06/24/2008 |
| K113131 | AMS | LIASYS 450 | 03/08/2012 |
| K080468 | AMS S.R.L. ANALYZER MEDICAL SYSTEM | LIASYS WITH MODELS LIASYS | 07/25/2008 |
| K011963 | BAYER CORP. | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | 11/20/2001 |
| K964004 | BAYER CORP. | GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS | 02/10/1997 |
| K971276 | BAYER CORP. | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER | 06/16/1997 |
| K052163 | BAYER HEALTHCARE, LLC | ADVIA IMS GLUCOSE ASSAY | 10/11/2005 |
| K060256 | BECKMAN COULTER, INC. | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM | 02/27/2006 |
| K131189 | BECKMAN COULTER, INC. | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | 04/17/2014 |
| K971467 | CAROLINA LIQUID CHEMISTRIES CORP. | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | 06/16/1997 |
| K980883 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY GLU-UL | 09/03/1998 |
| K031135 | DADE BEHRING, INC. | GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) | 06/02/2003 |
| K970664 | DERMA MEDIA LAB., INC. | GLUCOSE REAGENT | 08/01/1997 |
| K961282 | DIAGNOSTIC CHEMICALS LTD. | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 | 06/21/1996 |
| K023739 | DIAGNOSTIC CHEMICALS LTD. | GLUCOSE-SL-C ASSAY, MODEL 257-30 | 01/17/2003 |
| K151487 | Diatron US, Inc. | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | 01/14/2016 |
| K000556 | ELAN DIAGNOSTICS | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | 05/17/2000 |
| K153644 | ELITechGroup | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | 09/07/2016 |
| K041052 | HEMAGEN DIAGNOSTICS, INC. | RAICHEM GLUCOSE UV (LIQUID) | 06/30/2004 |
| K012668 | HEMAGEN DIAGNOSTICS, INC. | RAICHEM GLUCOSE UV REAGENT | 10/15/2001 |
| K061879 | HEMODIAGNOSTICA, LLC | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM | 12/15/2006 |
| K960084 | HI CHEM, INC. | HICHEM GLUCOSE/HK REAGENT KIT | 04/04/1996 |
| K120369 | HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | 05/10/2012 |
| K052007 | HORIBA ABX | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | 12/16/2005 |
| K081276 | HORIBA ABX | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | 09/12/2008 |
| K103788 | HORIBA ABX SAS | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | 11/08/2011 |
| K011900 | JAS Diagnostics, Inc. | GLUCOSE (HEXOKINASE) | 07/31/2001 |
| K092506 | MEDICA CORP. | EASYRA GLU-H REAGENT, MODEL 10200 | 09/16/2009 |
| K962435 | ORASURE TECHNOLOGIES, INC. | STC AUTO-LYTE URINARY GLUCOSE ASSAY | 12/26/1996 |
| K971754 | POINTE SCIENTIFIC, INC. | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | 07/22/1997 |
| K002199 | POINTE SCIENTIFIC, INC. | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | 11/20/2000 |
| K062118 | POINTE SCIENTIFIC, INC. | POINTE 360 | 07/13/2007 |
| K090703 | POLYMEDCO, INC. | POLY-CHEM 90 GLUCOSE | 10/20/2009 |
| K020852 | POLYMEDCO, INC. | POLY-CHEM GLUCOSE | 07/03/2002 |
| K953210 | RANDOX LABORATORIES, LTD. | GLUCOSE (HEXOKINASE) KIT | 10/25/1996 |
| K953847 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE REAGENT FOR GLUCOSE | 02/13/1996 |
| K092603 | Roche Diagnostics | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | 12/04/2009 |
| K220134 | Roche Diagnostics | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | 09/16/2022 |
| K191899 | Roche Diagnostics | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | 08/16/2019 |
| K061048 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM | 05/17/2006 |
| K062239 | ROCHE DIAGNOSTICS CORP. | GLUCOSE HK NEW FORMULATION TEST SYSTEM | 09/11/2006 |
| K072018 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | 02/01/2008 |
| K112377 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | 03/23/2012 |
| K101854 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | 03/07/2011 |
| K120681 | Siemens Healthcare Diagnostics Inc. | ADVIA CHEMISTRY GLUH_3 REAGENTS | 05/15/2012 |
| K984574 | SIGMA DIAGNOSTICS, INC. | INFINITY GLUCOSE REAGENT | 02/11/1999 |
| K001403 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | 08/10/2000 |
| K000102 | TECO DIAGNOSTICS | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | 02/08/2000 |
| K042767 | THERMO ELECTRON CORPORATION | DATAPRO CLINICAL CHELISTRY ANALYZER | 04/27/2005 |
| K103531 | TOKYO BOEKI MEDISYS INC. | PRESTIGE 24I; BIOLIS 24I; MGC 240 | 12/01/2011 |
| K980026 | TRACE AMERICA, INC. | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | 03/10/1998 |
| K080123 | WAKO CHEMICALS USA, INC. | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | 07/17/2008 |
| K024281 | WAKO CHEMICALS, USA, INC. | WAKO L-TYPE GLUCOSE 2 | 02/24/2003 |
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