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Hexokinase, Glucose

FDA product code CFR · 144 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1345
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-26 – 2026-02-12

CFR 2026-02-12

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Applicant Roche Diagnostics

K number K253490

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CFR 2025-10-24

Glucose2

Applicant Abbott Ireland

K number K252357

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CFR 2022-09-16

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

Applicant Roche Diagnostics

K number K220134

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CFR 2019-08-16

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

Applicant Roche Diagnostics

K number K191899

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CFR 2017-10-19

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

Applicant Abbott Laboratories

K number K170316

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CFR 2016-09-07

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

Applicant Elitechgroup

K number K153644

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CFR 2016-01-14

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

Applicant Diatron U.S., Inc.

K number K151487

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CFR 2013-04-23

ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K123018

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CFR 2012-05-15

ADVIA CHEMISTRY GLUH_3 REAGENTS

Applicant Siemens Healthcare Diagnostics, Inc.

K number K120681

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CFR 2012-05-10

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)

Applicant Hitachi Chemical Diagnostics, Inc.

K number K120369

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CFR 2012-03-23

BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K112377

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CFR 2012-03-08

LIASYS 450

Applicant Ams

K number K113131

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CFR 2011-12-01

PRESTIGE 24I; BIOLIS 24I; MGC 240

Applicant Tokyo Boeki Medisys, Inc.

K number K103531

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CFR 2011-11-08

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

Applicant HORIBA ABX SAS

K number K103788

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CFR 2011-03-07

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429

Applicant Siemens Healthcare Diagnostics

K number K101854

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CFR 2009-12-04

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

Applicant Roche Diagnostics

K number K092603

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CFR 2009-10-20

POLY-CHEM 90 GLUCOSE

Applicant Polymedco, Inc.

K number K090703

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CFR 2009-09-16

EASYRA GLU-H REAGENT, MODEL 10200

Applicant Medica Corp.

K number K092506

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CFR 2008-09-12

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

Applicant Horiba Abx

K number K081276

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CFR 2008-07-25

LIASYS WITH MODELS LIASYS

Applicant Ams S.R.L. Analyzer Medical System

K number K080468

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CFR 2008-07-17

APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201

Applicant Wako Chemicals USA, Inc.

K number K080123

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CFR 2008-06-24

S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K072140

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CFR 2008-02-01

BS-200 CHEMISTRY ANALYZER, MODE BS-200

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K072018

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CFR 2007-07-13

POINTE 360

Applicant Pointe Scientific, Inc.,

K number K062118

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CFR 2006-12-15

SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM

Applicant Hemodiagnostica, LLC

K number K061879

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CFR 2006-09-11

GLUCOSE HK NEW FORMULATION TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K062239

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CFR 2006-05-17

COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K061048

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CFR 2006-05-05

GLUCOSE

Applicant Abbott Laboratories

K number K060383

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CFR 2006-02-27

UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

Applicant Beckman Coulter, Inc.

K number K060256

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CFR 2005-12-16

ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

Applicant Horiba Abx

K number K052007

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CFR 2005-10-11

ADVIA IMS GLUCOSE ASSAY

Applicant Bayer Healthcare, LLC

K number K052163

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CFR 2005-04-27

DATAPRO CLINICAL CHELISTRY ANALYZER

Applicant Thermo Electron Corporation

K number K042767

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CFR 2004-06-30

RAICHEM GLUCOSE UV (LIQUID)

Applicant Hemagen Diagnostics, Inc.

K number K041052

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CFR 2003-06-02

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

Applicant Dade Behring, Inc.

K number K031135

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CFR 2003-02-24

WAKO L-TYPE GLUCOSE 2

Applicant Wako Chemicals USA, Inc.

K number K024281

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CFR 2003-01-17

GLUCOSE-SL-C ASSAY, MODEL 257-30

Applicant Diagnostic Chemicals , Ltd.

K number K023739

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CFR 2002-07-03

POLY-CHEM GLUCOSE

Applicant Polymedco, Inc.

K number K020852

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CFR 2001-11-20

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

Applicant Bayer Corp.

K number K011963

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CFR 2001-10-15

RAICHEM GLUCOSE UV REAGENT

Applicant Hemagen Diagnostics, Inc.

K number K012668

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CFR 2001-07-31

GLUCOSE (HEXOKINASE)

Applicant Jas Diagnostics, Inc.

K number K011900

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CFR 2000-11-20

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K002199

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CFR 2000-08-10

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

Applicant Sigma Diagnostics, Inc.

K number K001403

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CFR 2000-05-17

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

Applicant Elan Diagnostics

K number K000556

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CFR 2000-02-08

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

Applicant Teco Diagnostics

K number K000102

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CFR 1999-05-25

GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02

Applicant A.P. Total Care, Inc.

K number K990981

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CFR 1999-02-11

INFINITY GLUCOSE REAGENT

Applicant Sigma Diagnostics, Inc.

K number K984574

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CFR 1998-09-03

N-ASSAY GLU-UL

Applicant Crestat Diagnostics, Inc.

K number K980883

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CFR 1998-05-07

GLU

Applicant Abbott Laboratories

K number K981185

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CFR 1998-03-10

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

Applicant Trace America, Inc.

K number K980026

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CFR 1997-08-01

GLUCOSE REAGENT

Applicant Derma Media Lab., Inc.

K number K970664

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CFR 1997-07-22

LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K971754

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CFR 1997-06-16

SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)

Applicant Carolina Liquid Chemistries Corp.

K number K971467

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CFR 1997-06-16

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER

Applicant Bayer Corp.

K number K971276

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CFR 1997-02-10

GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS

Applicant Bayer Corp.

K number K964004

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CFR 1996-12-26

STC AUTO-LYTE URINARY GLUCOSE ASSAY

Applicant OraSure Technologies, Inc.

K number K962435

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CFR 1996-10-25

GLUCOSE (HEXOKINASE) KIT

Applicant Randox Laboratories, Ltd.

K number K953210

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CFR 1996-06-21

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60

Applicant Diagnostic Chemicals , Ltd.

K number K961282

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CFR 1996-04-04

HICHEM GLUCOSE/HK REAGENT KIT

Applicant Hi Chem, Inc.

K number K960084

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CFR 1996-02-13

ROCHE REAGENT FOR GLUCOSE

Applicant Roche Diagnostic Systems, Inc.

K number K953847

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CFR 1995-10-03

DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

Applicant Data Medical Associates, Inc.

K number K952437

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CFR 1995-06-01

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION

Applicant Heraeus Kulzer, Inc.

K number K951058

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CFR 1995-05-08

GLUCOSE (HK) REAGENT (PROCEDURE NO.16)

Applicant Sigma Diagnostics, Inc.

K number K945908

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CFR 1995-03-15

OLYMPUS GLUCOSE REAGENT

Applicant Olympus America, Inc.

K number K944406

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CFR 1994-12-29

GLUCOSE QVET

Applicant Prisma Systems

K number K942963

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CFR 1993-12-07

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION

Applicant Heraeus Kulzer, Inc.

K number K934900

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CFR 1993-10-12

IL TEST GLUCOSE

Applicant Instrumentation Laboratory CO

K number K931402

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CFR 1993-07-22

GLUCOSE-HK TEST

Applicant Em Diagnostic Systems, Inc.

K number K931890

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CFR 1993-06-24

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER

Applicant Heraeus Kulzer, Inc.

K number K926361

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CFR 1993-01-27

ROCHE COBAS FUTURA GLUCOSE

Applicant Roche Diagnostic Systems, Inc.

K number K922811

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CFR 1992-12-03

OLYMPUS GLUCOSE REAGENT

Applicant Olympus Corp.

K number K924601

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CFR 1992-11-25

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415

Applicant Em Diagnostic Systems, Inc.

K number K924572

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CFR 1992-11-02

KING DIAGNOSTICS GLUCOSE (HK) REAGENT

Applicant King Diagnostics, Inc.

K number K923129

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CFR 1992-09-23

ENCORE TEST STRIPS

Applicant Heraeus Kulzer, Inc.

K number K923018

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CFR 1992-09-15

MILES URINE GLUCOSE METHOD

Applicant Heraeus Kulzer, Inc.

K number K923040

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CFR 1992-07-16

OLYMPUS GLUCOSE REAGENT

Applicant Olympus Corp.

K number K922232

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CFR 1991-12-18

TECHNICON CHEM 1 PLASMA GLUCOSE

Applicant Heraeus Kulzer, Inc.

K number K914794

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CFR 1991-07-30

ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15

Applicant Em Diagnostic Systems, Inc.

K number K912808

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CFR 1991-07-18

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST

Applicant King Diagnostics, Inc.

K number K912251

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CFR 1991-03-11

GLUCOSE (HK) REAGENT, UNIVERSAL

Applicant Enzyme Technology, Inc.

K number K905227

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CFR 1991-01-04

ECLIPSE ICA GLUCOSE

Applicant Biotope, Inc.

K number K905144

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CFR 1990-03-29

TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE

Applicant Technicon Instruments Corp.

K number K901122

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CFR 1990-03-09

COULTER GLUCOSE REAGENT

Applicant Coulter Electronics, Inc.

K number K897160

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CFR 1989-11-14

GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600

Applicant American Research Products Co.

K number K896028

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CFR 1989-10-03

ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT

Applicant Abbott Laboratories

K number K894394

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CFR 1989-09-07

GLUCOSE-HK TEST (GLU-HK) ITEM #65415

Applicant Em Diagnostic Systems, Inc.

K number K894483

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CFR 1989-06-20

AMRESCO PRODUCT NUMBER 7426

Applicant American Research Products Co.

K number K891923

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CFR 1989-01-03

GLUCOSE-HK TEST (GLUC-HK) ITEM #65665

Applicant Em Diagnostic Systems, Inc.

K number K884736

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CFR 1988-11-10

EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95

Applicant Em Diagnostic Systems, Inc.

K number K884021

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CFR 1988-08-09

ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT

Applicant Abbott Laboratories

K number K882334

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CFR 1988-03-15

GLUCOSE HEXOKINASE

Applicant Tech-Neal Scientific, Inc.

K number K880236

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CFR 1988-03-03

GLUCOSE (HEXOKINASE)

Applicant Tech-Co, Inc.

K number K874846

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CFR 1987-11-24

GLUCOSE-HK REAGENT

Applicant Intersect Systems, Inc.

K number K873835

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CFR 1987-11-23

MODIFIED PARAMAX GLUCOSE REAGENT

Applicant Baxter Healthcare Corp

K number K873936

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CFR 1987-06-05

MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919

Applicant Simmler, Inc.

K number K871976

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CFR 1987-04-29

ULTRA-VIOLET GLUCOSE REAGENT KIT

Applicant Biochemical Trade, Inc.

K number K871456

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CFR 1986-09-26

GLUCOSE HK PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863259

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CFR 1986-04-24

GLUCOSE (HEXOKINASE) REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K861311

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CFR 1986-04-07

ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)

Applicant Trace Scientific , Ltd.

K number K860724

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CFR 1986-03-17

GLUCOSE HK-60 ASSAY KIT CAT. #201-39

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K860625

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CFR 1986-01-14

GLUCOSE (UV HEXOKIASE) REAGENT SET

Applicant Technostics Intl.

K number K855153

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