Panels › Clinical Chemistry › Product code CFR · Class 2
Hexokinase, Glucose
Regulation 862.1345
1510(k)s in 12 months (145 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
Top companies in CFR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2026 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions Roche Diagnostics | CFR |
| Oct 24, 2025 | K252357 | Glucose2 Abbott Ireland, IE | CFR |
| Sep 16, 2022 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH Roche Diagnostics | CFR |
| Aug 16, 2019 | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics | CFR |
| Oct 19, 2017 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM Abbott Laboratories | CFR |
| Sep 7, 2016 | K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITRO Elitechgroup, FR | CFR |
| Jan 14, 2016 | K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method Diatron U.S., Inc. | CFR |
| Apr 17, 2014 | K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) Beckman Coulter, Inc. | CFR |
| Apr 23, 2013 | K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE Alfa Wassermann Diagnostic Technologies, Inc. | CFR |
| May 15, 2012 | K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS Siemens Healthcare Diagnostics, Inc. | CFR |
| May 10, 2012 | K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) Hitachi Chemical Diagnostics, Inc. | CFR |
| Mar 23, 2012 | K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CFR |
| Mar 8, 2012 | K113131 | LIASYS 450 Ams, IT | CFR |
| Dec 1, 2011 | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 Tokyo Boeki Medisys, Inc. | CFR |
| Nov 8, 2011 | K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS, FR | CFR |
| Mar 7, 2011 | K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 Siemens Healthcare Diagnostics | CFR |
| Dec 4, 2009 | K092603 | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY Roche Diagnostics | CFR |
| Oct 20, 2009 | K090703 | POLY-CHEM 90 GLUCOSE Polymedco, Inc. | CFR |
| Sep 16, 2009 | K092506 | EASYRA GLU-H REAGENT, MODEL 10200 Medica Corp. | CFR |
| Sep 12, 2008 | K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H Horiba Abx, FR | CFR |
| Jul 25, 2008 | K080468 | LIASYS WITH MODELS LIASYS Ams S.R.L. Analyzer Medical System, IT | CFR |
| Jul 17, 2008 | K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 Wako Chemicals USA, Inc. | CFR |
| Jun 24, 2008 | K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU Alfa Wassermann Diagnostic Technologies, Inc. | CFR |
| Feb 1, 2008 | K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CFR |
| Jul 13, 2007 | K062118 | POINTE 360 Pointe Scientific, Inc., | CFR |
| Dec 15, 2006 | K061879 | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM Hemodiagnostica, LLC | CFR |
| Sep 11, 2006 | K062239 | GLUCOSE HK NEW FORMULATION TEST SYSTEM Roche Diagnostics Corp. | CFR |
| May 17, 2006 | K061048 | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM Roche Diagnostics Corp. | CFR |
| May 5, 2006 | K060383 | GLUCOSE Abbott Laboratories | CFR |
| Feb 27, 2006 | K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc. | CFR |
| Dec 16, 2005 | K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) Horiba Abx, FR | CFR |
| Oct 11, 2005 | K052163 | ADVIA IMS GLUCOSE ASSAY Bayer Healthcare, LLC | CFR |
| Apr 27, 2005 | K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER Thermo Electron Corporation | CFR |
| Jun 30, 2004 | K041052 | RAICHEM GLUCOSE UV (LIQUID) Hemagen Diagnostics, Inc. | CFR |
| Jun 2, 2003 | K031135 | GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) Dade Behring, Inc. | CFR |
| Feb 24, 2003 | K024281 | WAKO L-TYPE GLUCOSE 2 Wako Chemicals USA, Inc. | CFR |
| Jan 17, 2003 | K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 Diagnostic Chemicals , Ltd., CA | CFR |
| Jul 3, 2002 | K020852 | POLY-CHEM GLUCOSE Polymedco, Inc. | CFR |
| Nov 20, 2001 | K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY Bayer Corp. | CFR |
| Oct 15, 2001 | K012668 | RAICHEM GLUCOSE UV REAGENT Hemagen Diagnostics, Inc. | CFR |
| Jul 31, 2001 | K011900 | GLUCOSE (HEXOKINASE) Jas Diagnostics, Inc. | CFR |
| Nov 20, 2000 | K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc., | CFR |
| Aug 10, 2000 | K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P Sigma Diagnostics, Inc. | CFR |
| May 17, 2000 | K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS Elan Diagnostics | CFR |
| Feb 8, 2000 | K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 Teco Diagnostics | CFR |
| May 25, 1999 | K990981 | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 A.P. Total Care, Inc. | CFR |
| Feb 11, 1999 | K984574 | INFINITY GLUCOSE REAGENT Sigma Diagnostics, Inc. | CFR |
| Sep 3, 1998 | K980883 | N-ASSAY GLU-UL Crestat Diagnostics, Inc. | CFR |
| May 7, 1998 | K981185 | GLU Abbott Laboratories | CFR |
| Mar 10, 1998 | K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | CFR |
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