Atlas FDA

CFR

145 FDA 510(k) clearances · Product code

63 daysmedian time to decision
207 days90th percentile
145clearances measured

FDA profile

Official device name
Hexokinase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2011: 43 · 2012: 49 · 2013: 36 · 2017: 13 · 2023: 29 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490)Roche Diagnostics2026-02-12
Glucose2 (K252357)Abbott Ireland2025-10-24
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134)Roche Diagnostics2022-09-16
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899)Roche Diagnostics2019-08-16
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316)Abbott Laboratories2017-10-19
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (K153644)Elitechgroup2016-09-07
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487)Diatron U.S., Inc.2016-01-14
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189)Beckman Coulter, Inc.2014-04-17
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018)Alfa Wassermann Diagnostic Technologies, Inc.2013-04-23
ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681)Siemens Healthcare Diagnostics, Inc.2012-05-15
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369)Hitachi Chemical Diagnostics, Inc.2012-05-10
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER (K112377)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-03-23
LIASYS 450 (K113131)Ams2012-03-08
PRESTIGE 24I; BIOLIS 24I; MGC 240 (K103531)Tokyo Boeki Medisys, Inc.2011-12-01
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT (K103788)HORIBA ABX SAS2011-11-08
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 (K101854)Siemens Healthcare Diagnostics2011-03-07
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY (K092603)Roche Diagnostics2009-12-04
POLY-CHEM 90 GLUCOSE (K090703)Polymedco, Inc.2009-10-20
EASYRA GLU-H REAGENT, MODEL 10200 (K092506)Medica Corp.2009-09-16
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H (K081276)Horiba Abx2008-09-12
LIASYS WITH MODELS LIASYS (K080468)Ams S.R.L. Analyzer Medical System2008-07-25
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (K080123)Wako Chemicals USA, Inc.2008-07-17
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU (K072140)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
BS-200 CHEMISTRY ANALYZER, MODE BS-200 (K072018)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008-02-01
POINTE 360 (K062118)Pointe Scientific, Inc.,2007-07-13
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM (K061879)Hemodiagnostica, LLC2006-12-15
GLUCOSE HK NEW FORMULATION TEST SYSTEM (K062239)Roche Diagnostics Corp.2006-09-11
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM (K061048)Roche Diagnostics Corp.2006-05-17
GLUCOSE (K060383)Abbott Laboratories2006-05-05
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256)Beckman Coulter, Inc.2006-02-27
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) (K052007)Horiba Abx2005-12-16
ADVIA IMS GLUCOSE ASSAY (K052163)Bayer Healthcare, LLC2005-10-11
DATAPRO CLINICAL CHELISTRY ANALYZER (K042767)Thermo Electron Corporation2005-04-27
RAICHEM GLUCOSE UV (LIQUID) (K041052)Hemagen Diagnostics, Inc.2004-06-30
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) (K031135)Dade Behring, Inc.2003-06-02
WAKO L-TYPE GLUCOSE 2 (K024281)Wako Chemicals USA, Inc.2003-02-24
GLUCOSE-SL-C ASSAY, MODEL 257-30 (K023739)Diagnostic Chemicals , Ltd.2003-01-17
POLY-CHEM GLUCOSE (K020852)Polymedco, Inc.2002-07-03
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY (K011963)Bayer Corp.2001-11-20
RAICHEM GLUCOSE UV REAGENT (K012668)Hemagen Diagnostics, Inc.2001-10-15
GLUCOSE (HEXOKINASE) (K011900)Jas Diagnostics, Inc.2001-07-31
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K002199)Pointe Scientific, Inc.,2000-11-20
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P (K001403)Sigma Diagnostics, Inc.2000-08-10
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS (K000556)Elan Diagnostics2000-05-17
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 (K000102)Teco Diagnostics2000-02-08
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 (K990981)A.P. Total Care, Inc.1999-05-25
INFINITY GLUCOSE REAGENT (K984574)Sigma Diagnostics, Inc.1999-02-11
N-ASSAY GLU-UL (K980883)Crestat Diagnostics, Inc.1998-09-03
GLU (K981185)Abbott Laboratories1998-05-07
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980026)Trace America, Inc.1998-03-10
GLUCOSE REAGENT (K970664)Derma Media Lab., Inc.1997-08-01
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K971754)Pointe Scientific, Inc.,1997-07-22
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (K971467)Carolina Liquid Chemistries Corp.1997-06-16
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER (K971276)Bayer Corp.1997-06-16
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS (K964004)Bayer Corp.1997-02-10
STC AUTO-LYTE URINARY GLUCOSE ASSAY (K962435)OraSure Technologies, Inc.1996-12-26
GLUCOSE (HEXOKINASE) KIT (K953210)Randox Laboratories, Ltd.1996-10-25
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 (K961282)Diagnostic Chemicals , Ltd.1996-06-21
HICHEM GLUCOSE/HK REAGENT KIT (K960084)Hi Chem, Inc.1996-04-04
ROCHE REAGENT FOR GLUCOSE (K953847)Roche Diagnostic Systems, Inc.1996-02-13
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (K952437)Data Medical Associates, Inc.1995-10-03
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION (K951058)Heraeus Kulzer, Inc.1995-06-01
GLUCOSE (HK) REAGENT (PROCEDURE NO.16) (K945908)Sigma Diagnostics, Inc.1995-05-08
OLYMPUS GLUCOSE REAGENT (K944406)Olympus America, Inc.1995-03-15
GLUCOSE QVET (K942963)Prisma Systems1994-12-29
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION (K934900)Heraeus Kulzer, Inc.1993-12-07
IL TEST GLUCOSE (K931402)Instrumentation Laboratory CO1993-10-12
GLUCOSE-HK TEST (K931890)Em Diagnostic Systems, Inc.1993-07-22
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER (K926361)Heraeus Kulzer, Inc.1993-06-24
ROCHE COBAS FUTURA GLUCOSE (K922811)Roche Diagnostic Systems, Inc.1993-01-27
OLYMPUS GLUCOSE REAGENT (K924601)Olympus Corp.1992-12-03
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 (K924572)Em Diagnostic Systems, Inc.1992-11-25
KING DIAGNOSTICS GLUCOSE (HK) REAGENT (K923129)King Diagnostics, Inc.1992-11-02
ENCORE TEST STRIPS (K923018)Heraeus Kulzer, Inc.1992-09-23
MILES URINE GLUCOSE METHOD (K923040)Heraeus Kulzer, Inc.1992-09-15
OLYMPUS GLUCOSE REAGENT (K922232)Olympus Corp.1992-07-16
TECHNICON CHEM 1 PLASMA GLUCOSE (K914794)Heraeus Kulzer, Inc.1991-12-18
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 (K912808)Em Diagnostic Systems, Inc.1991-07-30
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST (K912251)King Diagnostics, Inc.1991-07-18
GLUCOSE (HK) REAGENT, UNIVERSAL (K905227)Enzyme Technology, Inc.1991-03-11
ECLIPSE ICA GLUCOSE (K905144)Biotope, Inc.1991-01-04
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE (K901122)Technicon Instruments Corp.1990-03-29
COULTER GLUCOSE REAGENT (K897160)Coulter Electronics, Inc.1990-03-09
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 (K896028)American Research Products Co.1989-11-14
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT (K894394)Abbott Laboratories1989-10-03
GLUCOSE-HK TEST (GLU-HK) ITEM #65415 (K894483)Em Diagnostic Systems, Inc.1989-09-07
AMRESCO PRODUCT NUMBER 7426 (K891923)American Research Products Co.1989-06-20
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 (K884736)Em Diagnostic Systems, Inc.1989-01-03
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 (K884021)Em Diagnostic Systems, Inc.1988-11-10
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT (K882334)Abbott Laboratories1988-08-09
GLUCOSE HEXOKINASE (K880236)Tech-Neal Scientific, Inc.1988-03-15
GLUCOSE (HEXOKINASE) (K874846)Tech-Co, Inc.1988-03-03
GLUCOSE-HK REAGENT (K873835)Intersect Systems, Inc.1987-11-24
MODIFIED PARAMAX GLUCOSE REAGENT (K873936)Baxter Healthcare Corp1987-11-23
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 (K871976)Simmler, Inc.1987-06-05
ULTRA-VIOLET GLUCOSE REAGENT KIT (K871456)Biochemical Trade, Inc.1987-04-29
GLUCOSE HK PROCEDURE (K863259)Data Medical Associates, Inc.1986-09-26
GLUCOSE (HEXOKINASE) REAGENT SET (K861311)Sterling Diagnostics, Inc.1986-04-24
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) (K860724)Trace Scientific , Ltd.1986-04-07
GLUCOSE HK-60 ASSAY KIT CAT. #201-39 (K860625)Diagnostic Chemicals, Ltd. (Usa)1986-03-17
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