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
K894394 ABBOTT LABORATORIES ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT 10/03/1989
K882334 ABBOTT LABORATORIES ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT 08/09/1988
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
K843541 ABBOTT LABORATORIES PDA GLUCOSE 09/28/1984
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
K782136 AMERICAN MONITOR CORP. GLUCOSE REAGENT SYSTEM 01/26/1979
K891923 AMERICAN RESEARCH PRODUCTS CO. AMRESCO PRODUCT NUMBER 7426 06/20/1989
K896028 AMERICAN RESEARCH PRODUCTS CO. GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 11/14/1989
K113131 AMS LIASYS 450 03/08/2012
K080468 AMS S.R.L. ANALYZER MEDICAL SYSTEM LIASYS WITH MODELS LIASYS 07/25/2008
K873936 BAXTER HEALTHCARE CORP. MODIFIED PARAMAX GLUCOSE REAGENT 11/23/1987
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
K770262 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GLUCOSE (HEXOKINASE) DELTA TEST ASSAY 02/23/1977
K780858 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE 06/22/1978
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
K802810 BECKMAN INSTRUMENTS, INC. HEXOKINASE, GLUCOSE 12/10/1980
K871456 BIOCHEMICAL TRADE, INC. ULTRA-VIOLET GLUCOSE REAGENT KIT 04/29/1987
K905144 BIOTOPE, INC. ECLIPSE ICA GLUCOSE 01/04/1991
K812303 BOEHRINGER MANNHEIM CORP. GLUCOSE-HK SYSTEM PACK TEST 09/01/1981
K971467 CAROLINA LIQUID CHEMISTRIES CORP. SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) 06/16/1997
K853826 CATACHEM, INC. GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS 09/30/1985
K897160 COULTER ELECTRONICS, INC. COULTER GLUCOSE REAGENT 03/09/1990
K980883 CRESTAT DIAGNOSTICS, INC. N-ASSAY GLU-UL 09/03/1998
K031135 DADE BEHRING, INC. GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) 06/02/2003
K801051 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI 05/23/1980
K801052 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME GLUCOSE HEXOKINASE UV 05/23/1980
K952437 DATA MEDICAL ASSOCIATES, INC. DMA GLUCOSE HEXOKINASE U.V. PROCEDURE 10/03/1995
K863259 DATA MEDICAL ASSOCIATES, INC. GLUCOSE HK PROCEDURE 09/26/1986
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
K842510 DIAGNOSTIC CHEMICALS, LTD. (USA) GLUCOSE ASSAY KIT-HEXOKINASE 07/20/1984
K860625 DIAGNOSTIC CHEMICALS, LTD. (USA) GLUCOSE HK-60 ASSAY KIT CAT. #201-39 03/17/1986
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
K912808 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 07/30/1991
K924572 EM DIAGNOSTIC SYSTEMS, INC. EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 11/25/1992
K884021 EM DIAGNOSTIC SYSTEMS, INC. EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 11/10/1988
K931890 EM DIAGNOSTIC SYSTEMS, INC. GLUCOSE-HK TEST 07/22/1993
K894483 EM DIAGNOSTIC SYSTEMS, INC. GLUCOSE-HK TEST (GLU-HK) ITEM #65415 09/07/1989
K884736 EM DIAGNOSTIC SYSTEMS, INC. GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 01/03/1989
K843150 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE GLUCOSE 67216 08/27/1984
K821470 EMD CHEMICALS INC. ULTRACHEM E-GLU #64976 & 65040 06/02/1982
K821475 EMD CHEMICALS INC. ULTRACHEM E-GLU #64976&65040 06/25/1982
K821461 EMD CHEMICALS INC. ULTRACHEM E-GLU, #64976 & 65040 06/02/1982
K761320 ENVIRONMENTAL CHEMICAL SPECIALTIES GLUCOSE KIT 01/25/1977
K905227 ENZYME TECHNOLOGY, INC. GLUCOSE (HK) REAGENT, UNIVERSAL 03/11/1991
K791760 FISHER SCIENTIFIC CO., LLC. GLUCOSE HEXOKINASE COIL REAGENT SYSTEM 09/27/1979
K790786 GILFORD DIAGNOSTICS GLUCOSE (HK) REAGENT 06/15/1979
K761240 HARLECO AUTO-ENZYMATIC GLUCOSE 12/29/1976
K770229 HARLECO AUTO-ENZYMATIC GLUCOSE 03/01/1977
K770886 HARLECO AUTO-ENZYMATIC GLUCOSE FOR ANALYZER 07/14/1977
K812595 HARLECO ULTRA CHEM E-GLU #64976 & 65040 09/29/1981
K780515 HARLECO ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM 05/19/1978
K780065 HARLECO ULTRACHEM E-GLU, MANUAL DETERM. 02/01/1978
K821868 HARLECO DIAGNOSTICS ULTRACHEM E-GLU 07/08/1982
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
K923018 HERAEUS KULZER, INC. ENCORE TEST STRIPS 09/23/1992
K926361 HERAEUS KULZER, INC. GLUCOMETER ENCORE QA BLOOD GLUCOSE METER 06/24/1993
K934900 HERAEUS KULZER, INC. GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION 12/07/1993
K951058 HERAEUS KULZER, INC. GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION 06/01/1995
K923040 HERAEUS KULZER, INC. MILES URINE GLUCOSE METHOD 09/15/1992
K914794 HERAEUS KULZER, INC. TECHNICON CHEM 1 PLASMA GLUCOSE 12/18/1991
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
K770311 ICN PHARMACEUTICALS, INC. GLUCOSE REAGENT, ENZYMATIC 03/30/1977
K801456 INSTRUMENTATION LABORATORY CO. F/LS MCA APPLICATION SOFTWARE 10/03/1980
K931402 INSTRUMENTATION LABORATORY CO. IL TEST GLUCOSE 10/12/1993
K771464 INSTRUMENTATION LABORATORY CO. MULTISTAT III GLUCOSE TEST 09/02/1977
K873835 INTERSECT SYSTEMS, INC. GLUCOSE-HK REAGENT 11/24/1987
K761345 J.T. BAKER CHEMICAL CO. GLUCO-HEX TM REAGENT KIT 01/05/1977
K011900 JAS Diagnostics, Inc. GLUCOSE (HEXOKINASE) 07/31/2001
K923129 KING DIAGNOSTICS, INC. KING DIAGNOSTICS GLUCOSE (HK) REAGENT 11/02/1992
K912251 KING DIAGNOSTICS, INC. KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST 07/18/1991
K792532 MACOMB CHEMICAL CO. GLUCOSE (HEXOKINASE) REAGENT SET 01/11/1980
K770844 MALLINCKRODT CRITICAL CARE FLUCOSE U.V. TEST KIT 07/14/1977
K771311 MALLINCKRODT CRITICAL CARE GLUCOSE REAGENT (HEXOHINASE) 08/03/1977
K092506 MEDICA CORP. EASYRA GLU-H REAGENT, MODEL 10200 09/16/2009
K781723 MEDICAL ANALYSIS SYSTEMS, INC. GLUCOSE HEXOKINASE, AUTO K 11/03/1978
K780072 MEDICAL ANALYSIS SYSTEMS, INC. GLUCOSE REAGENT SET 02/14/1978
K853464 MEDICAL ANALYSIS SYSTEMS, INC. GLUCOSE SR LIQUID STABLE REAGENT SET 09/04/1985
K944406 OLYMPUS AMERICA, INC. OLYMPUS GLUCOSE REAGENT 03/15/1995
K922232 OLYMPUS CORP. OLYMPUS GLUCOSE REAGENT 07/16/1992
K924601 OLYMPUS CORP. OLYMPUS GLUCOSE REAGENT 12/03/1992
K962435 ORASURE TECHNOLOGIES, INC. STC AUTO-LYTE URINARY GLUCOSE ASSAY 12/26/1996
K832872 POINTE SCIENTIFIC, INC. HEXOKINASE, GLUCOSE 10/14/1983
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
K942963 PRISMA SYSTEMS GLUCOSE QVET 12/29/1994
K953210 RANDOX LABORATORIES, LTD. GLUCOSE (HEXOKINASE) KIT 10/25/1996
K801765 REAGENTS APPLICATIONS, INC. GLUCOSE REAGENT(UV-HEXOKINASE) 09/16/1980
K801297 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR GLUCOSE RAPID 06/30/1980
K922811 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS FUTURA GLUCOSE 01/27/1993
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
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
K831560 SCLAVO, INC. GLUCOSE HEXOKINASE DIAG. KIT 07/06/1983
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
K760247 SIGMA CHEMICAL CO. GLUCOSE REAGENT SYS, SIGMA PROCED. 115 08/26/1976
K841555 SIGMA CHEMICAL CO. SIGMA PROCEDURE 16-UV 05/22/1984
K945908 SIGMA DIAGNOSTICS, INC. GLUCOSE (HK) REAGENT (PROCEDURE NO.16) 05/08/1995
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
K871976 SIMMLER, INC. MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 06/05/1987
K811849 SMITH KLINE DIAGNOSTICS, INC. ESKAFLOW TEST FOR GLUCOSE 07/15/1981
K760055 SMITH KLINE DIAGNOSTICS, INC. REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER 08/26/1976
K844998 STERLING BIOCHEMICAL, INC. GLUCOSE(HEXOKINASE) REAGENT SET 01/18/1985
K861311 STERLING DIAGNOSTICS, INC. GLUCOSE (HEXOKINASE) REAGENT SET 04/24/1986
K874846 TECH-CO, INC. GLUCOSE (HEXOKINASE) 03/03/1988
K880236 TECH-NEAL SCIENTIFIC, INC. GLUCOSE HEXOKINASE 03/15/1988
K771384 TECHNICON INSTRUMENTS CORP. AUTOZYME IMMOBILIZED ENZYME COIL 08/22/1977
K901122 TECHNICON INSTRUMENTS CORP. TECHNICON CHEM 1 CLINICAL ANALYZER "URINE GLUCOSE" 03/29/1990
K855153 TECHNOSTICS INTL. GLUCOSE (UV HEXOKIASE) REAGENT SET 01/14/1986
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
K860724 TRACE SCIENTIFIC LTD. ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) 04/07/1986
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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