Glucose Oxidase, Glucose

FDA product code CGA · 392 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: 1976-10-05 – 2026-05-01

CGA 2002-08-30

EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

Applicant Chay Medical, LLC

K number K021781

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CGA 2002-06-28

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K021943

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CGA 2002-04-03

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706

Applicant Hemocue, Inc.

K number K020935

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CGA 2002-03-21

DIABETES ASSISTANT SOFTWARE

Applicant Roche Diagnostics Corp.

K number K014139

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CGA 2002-02-15

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

Applicant Chay Medical, LLC

K number K013342

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CGA 2002-02-12

HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Hypoguard USA, Inc.

K number K020232

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CGA 2001-12-21

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

Applicant Wiener Laboratories Saic

K number K011953

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CGA 2001-11-30

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

Applicant Inverness Medical Innovations, Inc.

K number K011479

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CGA 2001-11-20

BIOSCANNER 2000

Applicant Polymer Technology Systems, Inc.

K number K013068

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CGA 2001-05-18

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

Applicant Apex BioTechnology Corp.

K number K011233

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CGA 2001-05-07

ATLAST DATA MANAGEMENT SOFTWARE (DMS)

Applicant Amira Medical, Inc.

K number K010605

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CGA 2001-05-07

GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS

Applicant Instrumentation Laboratory CO

K number K010520

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CGA 2001-03-15

RANDOX GLUCOSE (GOD/PAP)

Applicant Randox Laboratories, Ltd.

K number K003346

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CGA 2001-02-01

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

Applicant Lxn Corp.

K number K002688

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CGA 2001-01-22

GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM

Applicant Apex BioTechnology Corp.

K number K002624

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CGA 2001-01-22

GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Apex BioTechnology Corp.

K number K002621

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CGA 2000-12-22

EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION

Applicant Cybercare Technologies, Inc.

K number K003257

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CGA 2000-12-18

SATURN BLOOD GLUCOSE MONITORING TEST STRIP

Applicant Lifescan, Inc.

K number K001441

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CGA 2000-10-05

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

Applicant I-Stat Corp.

K number K001387

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CGA 2000-09-05

CAMIT DIABETES MANAGEMENT SOFTWARE

Applicant Roche Diagnostics Corp.

K number K001907

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CGA 2000-08-07

ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K002134

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CGA 2000-07-26

GENERIC BLOOD GLUCOSE TEST STRIP

Applicant Inbios Intl., Inc.

K number K001092

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CGA 2000-06-02

MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K001427

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CGA 2000-03-17

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K000583

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CGA 2000-02-23

ACCU-CHEK ADVANTAGE METER

Applicant Roche Diagnostics Corp.

K number K000365

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CGA 1999-12-16

AVL OPTI CRITICAL CARE ANALYZER

Applicant Avl Scientific Corp.

K number K993837

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CGA 1999-11-23

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]

Applicant Health Hero Network, Inc.

K number K993128

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CGA 1999-11-12

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K993632

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CGA 1999-09-24

PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM

Applicant Home Diagnostics, Inc.

K number K992988

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CGA 1999-09-17

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

Applicant Selfcare, Inc.

K number K991480

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CGA 1999-09-08

GO GLUCOSE MONITORING SYSTEM

Applicant Lxn Corp.

K number K991754

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CGA 1999-08-02

DUET II GLUCOSE CONTROL MONITORING SYSTEM

Applicant Lxn Corp.

K number K990942

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CGA 1999-07-09

GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS

Applicant Bayer Corp.

K number K990649

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CGA 1999-07-09

PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST

Applicant Medisense, Inc.

K number K983504

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CGA 1999-06-30

GLUCOMETER ELITE TEST STRIPS

Applicant Bayer Corp.

K number K991242

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CGA 1999-06-22

DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL

Applicant Dade Behring, Inc.

K number K983344

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CGA 1999-05-21

SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K984261

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CGA 1999-04-29

IN TOUCH DIABETES MANAGEMENT SOFTWARE

Applicant Lifescan, Inc.

K number K984527

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CGA 1999-04-20

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K990939

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CGA 1999-03-18

GLUCOMETER ELITE XL BLOOD GLUCOSE METER

Applicant Bayer Corp.

K number K984006

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CGA 1998-12-10

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM

Applicant Amira Medical, Inc.

K number K982076

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CGA 1998-12-08

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST

Applicant Medisense, Inc.

K number K982303

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CGA 1998-07-30

SENSOREX BLOOD GLUCOSE MONITORING SYSTEM

Applicant Chronimed, Inc.

K number K980573

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CGA 1998-05-07

CARESIDE GLUCOSE

Applicant Exigent Diagnostics, Inc.

K number K981183

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CGA 1998-01-26

ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K974451

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CGA 1998-01-22

MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON

Applicant Polymer Technology Systems, Inc.

K number K972669

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CGA 1998-01-02

GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM

Applicant Clinical Diagnostics, Inc.

K number K971653

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CGA 1997-12-16

ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK

Applicant Lifescan, Inc.

K number K972473

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CGA 1997-10-31

DUET GLUCOSE CONTROL MONITORING SYSTEM

Applicant Lxn Corp.

K number K973140

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CGA 1997-09-17

GLUCOSITE TEST SYSTEM

Applicant Gds Technology, LLC

K number K971145

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CGA 1997-09-09

AVL OMNI ANALYZER

Applicant Avl Scientific Corp.

K number K972733

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CGA 1997-08-08

PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP

Applicant Medisense, Inc.

K number K971812

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CGA 1997-06-20

ELECT II BLOOD GLUCOSE MONITORING SYSTEM

Applicant Selfcare, Inc.

K number K970707

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CGA 1997-05-12

SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K970556

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CGA 1997-04-21

LIQUID GLUCOSE (OXIDASE) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K970781

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CGA 1997-02-20

PRECISION G BLOOD GLUCOSE TESTING SYSTEM

Applicant Medisense, Inc.

K number K963676

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CGA 1997-02-20

SUPREME II METER

Applicant Chronimed, Inc.

K number K963544

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CGA 1997-02-10

GLUCOMETER ELITE BLOOD GLUCOSE METER

Applicant Bayer Corp.

K number K964630

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CGA 1997-01-21

GLUCOMETER DEX DIABETES CARE SYSTEM

Applicant Bayer Corp.

K number K963500

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CGA 1997-01-17

SIGMA DIAGNOSTICS GLUCOSE REAGENT

Applicant Sigma Diagnostics, Inc.

K number K963535

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CGA 1996-11-07

PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL

Applicant Home Diagnostics, Inc.

K number K960855

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CGA 1996-09-24

AMD HOME HEALTH MONITORING SYSTEM

Applicant Advanced Medical Devices, Inc.

K number K960337

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CGA 1996-09-05

ELECT BLOOD GLUCOSE MONITORIG SYSTEM

Applicant Selfcare, Inc.

K number K961985

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CGA 1996-08-16

SAFESTRIP

Applicant Firehouse Medical, Inc.

K number K955107

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CGA 1996-07-26

PRECISION QID BLOOD GLUCOSE TEST STRIP

Applicant Medisense, Inc.

K number K962295

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CGA 1996-07-23

CHEMCARD GLUCOSE TEST

Applicant Chem-Elec, Inc.

K number K943503

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CGA 1996-06-28

SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM

Applicant Selfcare, Inc.

K number K960053

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CGA 1996-06-28

LXN BLOOD GLUCOSE TEST SYSTEM

Applicant Lxn Corp.

K number K960034

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CGA 1996-06-21

EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM

Applicant Medisense, Inc.

K number K961337

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CGA 1996-05-17

EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K955286

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CGA 1996-04-17

ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM

Applicant Boehringer Mannheim Corp.

K number K944459

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CGA 1996-02-22

GLUCOCHEK POCKETLAB

Applicant Clinical Diagnostics, Inc.

K number K951457

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CGA 1995-11-21

ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS

Applicant Boehringer Mannheim Corp.

K number K952875

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CGA 1995-11-08

FIRST CHOICE TEST STRIP

Applicant Polymer Technology Intl.

K number K950628

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CGA 1995-11-08

FIRST CHOICE(TM) TEST STRIP

Applicant Polymer Technology Intl.

K number K946166

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CGA 1995-10-17

EML105 ELECTROLYTE METABOLITE ANALYZER

Applicant Radiometer America, Inc.

K number K952621

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CGA 1995-10-05

WAKO AUTOKIT GLUCOSE

Applicant Wako Chemicals USA, Inc.

K number K950172

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CGA 1995-07-14

GLUCOMETER ELITE M BLOOD GLUCOSE METER

Applicant Bayer Corp.

K number K951537

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CGA 1995-07-03

ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K950816

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CGA 1995-06-14

PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM

Applicant Medisense, Inc.

K number K952279

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CGA 1995-06-01

ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM

Applicant Lifescan, Inc.

K number K950727

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CGA 1995-03-24

LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K942455

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CGA 1995-03-23

PRECISION Q I D BLOOD GLUCOSE TEST STRIPS

Applicant Medisense, Inc.

K number K945887

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CGA 1995-03-23

QUICKPRO BLOOD GLUCOSE TESTING SYSTEM

Applicant Medisense, Inc.

K number K944195

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CGA 1995-01-17

HEMOCUE B-GLUCOSE SYSTEM

Applicant Hemocue, Inc.

K number K943432

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CGA 1995-01-17

GLUCOCHEK

Applicant Clinical Diagnostics, Inc.

K number K940215

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CGA 1994-11-04

SIGMA GLUCOSE REAGENT

Applicant Sigma Chemical Co.

K number K933694

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CGA 1994-10-20

DMA GLUCOSE (OXIDASE) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K943241

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CGA 1994-05-10

GLUCOFILM TEST STRIPS

Applicant Heraeus Kulzer, Inc.

K number K936212

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CGA 1994-01-11

RELIEF PLUS ONE REAGENT STRIP MODIFICATION

Applicant Diagnostic Solutions, Inc.

K number K934892

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CGA 1993-12-07

GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION

Applicant Heraeus Kulzer, Inc.

K number K934898

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CGA 1993-12-07

APEC GLUCOSE ANALYZER

Applicant Apec, Inc.

K number K931196

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CGA 1993-11-10

GLUCOSTIX REAGENT STRIPS

Applicant Heraeus Kulzer, Inc.

K number K926362

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CGA 1993-11-09

CHOLESTECH L.D.X. SYSTEM

Applicant Cholestech Corp.

K number K932727

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CGA 1993-09-08

ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM

Applicant Boehringer Mannheim Corp.

K number K930979

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CGA 1993-09-08

GLUCOFILM TEST STRIPS

Applicant Heraeus Kulzer, Inc.

K number K926360

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CGA 1993-08-10

DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP

Applicant Home Diagnostics, Inc.

K number K922137

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CGA 1993-08-10

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP

Applicant Home Diagnostics, Inc.

K number K922136

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CGA 1993-06-25

GLUCOMETER M+ BLOOD GLUCOSE METER

Applicant Heraeus Kulzer, Inc.

K number K931310

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CGA 1993-06-15

TES-TAPE

Applicant Lilly Research Laboratories

K number K922207

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