System, Test, Blood Glucose, Over The Counter

FDA product code NBW · 454 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1345
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2001-03-26 – 2026-08-27

NBW 2005-01-03

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

Applicant Bionime Corporation

K number K042678

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NBW 2004-12-22

ASCENSIA ELITE DIABETES CARE SYSTEM

Applicant Bayer Healthcare, LLC

K number K043311

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NBW 2004-12-22

ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Bayer Healthcare, LLC

K number K043158

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NBW 2004-08-27

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222

Applicant Taidoc Technology Corporation

K number K042005

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NBW 2004-08-11

EZ SMART

Applicant Vip International Wholesalers, Corp.

K number K040848

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NBW 2004-07-23

PTS PANELS CHOL+GLU TEST PANEL

Applicant Polymer Technology Systems, Inc.

K number K041750

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NBW 2004-07-14

EUSURE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Eumed Biotechnology Co., Ltd.

K number K040678

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NBW 2004-06-18

TAIDOC CHECK

Applicant Taidoc Technology Corporation

K number K041107

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NBW 2004-05-19

PARADIGM LINK BLOOD GLUCOSE METER

Applicant Becton, Dickinson & CO

K number K040603

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NBW 2004-04-15

MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM

Applicant Abbott Laboratories

K number K040814

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NBW 2004-03-25

MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL

Applicant Home Diagnostics, Inc.

K number K040670

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NBW 2004-03-25

PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM

Applicant Abbott Laboratories

K number K040628

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NBW 2004-03-24

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)

Applicant Home Diagnostics, Inc.

K number K032657

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NBW 2004-01-08

PRECISION XCEED DIABETES MONITORING SYSTEM

Applicant Abbott Laboratories

K number K033845

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NBW 2003-12-19

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005

Applicant Abbott Diabetes Care, Inc.

K number K031260

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NBW 2003-12-18

BTG SMARTEST GLUCOSE TEST SYSTEM

Applicant Bt Medical

K number K032029

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NBW 2003-10-21

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

Applicant Hmd Biomedical, Inc.

K number K032985

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NBW 2003-10-16

EASYGLUCO, MODEL IGM0002

Applicant American Healthcare, Inc.

K number K031501

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NBW 2003-09-12

ACCU-CHEK ADVANTAGE SYSTEM

Applicant Roche Diagnostics Corp.

K number K032552

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NBW 2003-08-04

GLUCOLEADER VALUE

Applicant Hmd Biomedical, Inc.

K number K023279

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NBW 2003-07-11

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS

Applicant Home Diagnostics, Inc.

K number K030703

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NBW 2003-07-03

MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Medline Industries, Inc.

K number K031843

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NBW 2003-04-23

PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO

Applicant Abbott Laboratories

K number K023256

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NBW 2003-02-07

ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS

Applicant Lifescan, Inc.

K number K024194

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NBW 2003-01-23

ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL

Applicant Bayer Corp.

K number K024234

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NBW 2002-12-13

SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K023832

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NBW 2002-12-06

BECTON DICKINSON DIABETES SOFTWARE

Applicant Becton, Dickinson & CO

K number K023219

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NBW 2002-11-20

ASCENSIA DEX 2 DIABETES CARE SYSTEM

Applicant Bayer Corp.

K number K023584

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NBW 2002-10-11

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

Applicant Hypoguard USA, Inc.

K number K022545

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NBW 2002-10-09

BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM

Applicant Becton, Dickinson & CO

K number K022581

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NBW 2002-09-12

SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K022724

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NBW 2002-09-09

MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM

Applicant Abbott Laboratories

K number K022182

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NBW 2002-08-23

ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K021819

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NBW 2002-07-23

ACCU-CHEK COMPACT SYSTEM

Applicant Roche Diagnostics Corp.

K number K022171

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NBW 2002-07-03

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM

Applicant Roche Diagnostics Corp.

K number K021827

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NBW 2002-06-11

ACCU-CHEK ADVANTAGE MODULE

Applicant Roche Diagnostics Corp.

K number K021513

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NBW 2002-06-11

FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM

Applicant Abbott Diabetes Care, Inc.

K number K020866

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NBW 2002-06-03

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM

Applicant Roche Diagnostics Corp.

K number K021448

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NBW 2002-04-30

GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)

Applicant Bayer Group Diagnostics

K number K020210

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NBW 2002-04-29

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

Applicant Bayer Group Diagnostics

K number K020208

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NBW 2002-02-28

SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

Applicant Abbott Laboratories

K number K012975

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NBW 2002-02-19

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM

Applicant Polymedica Pharmaceuticals, U.S.A., Inc.]

K number K014167

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NBW 2001-12-21

BIOSCANNER PLUS

Applicant Polymer Technology Systems, Inc.

K number K014099

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NBW 2001-12-05

ACCU-CHEK ACTIVE TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K012324

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NBW 2001-12-05

MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Abbott Diabetes Care, Inc.

K number K012014

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NBW 2001-11-16

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS

Applicant Polymer Technology Systems, Inc.

K number K013203

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NBW 2001-09-13

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

Applicant Medline Industries, Inc.

K number K011240

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NBW 2001-09-12

GLUCOMETER DEX TEST SENSOR

Applicant Bayer Corp.

K number K012205

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NBW 2001-08-10

QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION

Applicant Chronimed, Inc.

K number K010039

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NBW 2001-08-09

MODIFICATION TO ACCU-CHEK INFORM METER

Applicant Roche Diagnostics Corp.

K number K012210

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NBW 2001-06-21

INDUO BLOOD GLUCOSE METER

Applicant Inverness Medical Innovations, Inc.

K number K011616

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NBW 2001-06-20

ACCU-CHEK ACTIVE SYSTEM

Applicant Roche Diagnostics Corp.

K number K011738

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NBW 2001-06-18

PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY

Applicant Abbott Laboratories

K number K010553

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NBW 2001-03-26

PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700

Applicant Home Diagnostics, Inc.

K number K010403

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