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 2016-11-10

FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

Applicant Taidoc Technology Corporation

K number K161738

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NBW 2016-09-28

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

Applicant Infopia Co, Ltd.

K number K160365

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NBW 2016-08-31

ACCU-CHEK Guide Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K number K160944

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NBW 2016-08-19

iHealth Align Gluco-Monitoring system

Applicant Andon Health Co, Ltd.

K number K153286

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NBW 2016-08-19

Wireless Smart Gluco-Monitoring System

Applicant Andon Health Co, Ltd.

K number K153278

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NBW 2016-08-05

On Call Pro Blood Glucose Monitoring System

Applicant Acon Laboratories

K number K161867

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NBW 2016-07-29

UniStrip1 Generic Blood Glucose Test Strips

Applicant Ok Biotech Co., Ltd.

K number K160038

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NBW 2016-07-20

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

Applicant Ok Biotech Co., Ltd.

K number K152599

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NBW 2016-06-24

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K number K160430

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NBW 2016-06-24

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

Applicant Sd Biosensor

K number K153201

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NBW 2016-06-23

StatStrip Xpress Blood Glucose Monitoring System

Applicant Nova Biomedical Corporation

K number K160156

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NBW 2016-04-25

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K number K152493

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NBW 2016-04-21

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System

Applicant Agamatrix, Inc.

K number K152365

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NBW 2016-04-01

TRUE METRIX GO Self Monitoring Blood Glucose System

Applicant Trividia Health, Inc.

K number K143548

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NBW 2016-02-19

FreeStyle Precision Neo H Blood Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K number K153330

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NBW 2016-01-08

MyGlucoHealth Wireless System

Applicant Entra Health Systems

K number K143169

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NBW 2013-12-24

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM

Applicant Abbott Diabetes Care, Inc.

K number K132511

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NBW 2013-12-20

ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM

Applicant ACON Laboratories, Inc.

K number K130284

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NBW 2013-12-19

SMARTLOG DIABETES MANAGEMENT SOFTWARE

Applicant I-Sens, Inc.

K number K133346

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NBW 2013-12-19

ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

Applicant ACON Laboratories, Inc.

K number K132086

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NBW 2013-12-12

HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K132862

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NBW 2013-12-05

GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K132966

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NBW 2013-11-26

PRODIGY CHOICE

Applicant Prodigy Diabetes Care, LLC

K number K122340

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NBW 2013-11-22

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

Applicant I-Sens, Inc.

K number K132288

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NBW 2013-11-22

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM

Applicant General Life Biotechnology Co., Ltd.

K number K123090

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NBW 2013-11-20

AGAMATRIX HEALTH MANAGER

Applicant Agamatrix, Inc.

K number K132821

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NBW 2013-11-06

UNISTRIP 1

Applicant Unistrip Technologies, LLC

K number K113135

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NBW 2013-11-05

PREFERRED BLOOD GLUCOSE MONITORING SYSTEM

Applicant Prodigy Diabetes Care, LLC

K number K122338

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NBW 2013-10-24

DA01 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Delbio Incorporation

K number K132338

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NBW 2013-10-17

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION

Applicant Glooko, Inc.

K number K132272

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NBW 2013-10-17

FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Nova Biomedical Corporation

K number K131013

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NBW 2013-09-26

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR

Applicant Bayer Healthcare

K number K122370

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NBW 2013-08-30

ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Cilag GmbH International

K number K131363

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NBW 2013-08-23

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM

Applicant Delbio Incorporation

K number K130244

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NBW 2013-08-21

CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

Applicant I-Sens, Inc.

K number K130696

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NBW 2013-08-15

TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

Applicant Nipro Diagnostics, Inc.

K number K132072

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NBW 2013-08-15

EBCHEK BLOOD GLUCOSE MONITORING SYSTEM

Applicant Visgeneer, Inc.

K number K122181

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NBW 2013-08-09

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

Applicant I-Sens, Inc.

K number K131419

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NBW 2013-08-09

ACCU-CHEK AVIVA PLUS TEST STRIP

Applicant Roche Diagnostics Operations, Inc.

K number K131029

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NBW 2013-07-31

GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K130181

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NBW 2013-07-30

BROADMASTER HEALTHCARE SYSTEM

Applicant Broadmaster Biotech Corporation

K number K130621

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NBW 2013-07-15

LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE

Applicant All Medicus Co., Ltd.

K number K130657

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NBW 2013-06-28

SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM

Applicant Biotest Medical Corp.

K number K123559

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NBW 2013-06-27

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM

Applicant Abbott Diabetes Care

K number K130094

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NBW 2013-06-21

LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.

Applicant Infopia Co, Ltd.

K number K130295

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NBW 2013-06-19

VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Mico Biomed Co., Ltd.

K number K123007

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NBW 2013-06-18

TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Tyson Bioresearch, Inc.

K number K123087

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NBW 2013-06-18

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS

Applicant Mico Biomed Co., Ltd.

K number K123016

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NBW 2013-05-16

FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Taidoc Technology Corporation

K number K124040

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NBW 2013-05-02

SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM

Applicant Biotest Medical Corp.

K number K122525

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NBW 2013-04-25

GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION

Applicant Glooko, Inc.

K number K130886

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NBW 2013-04-24

TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

Applicant Nipro Diagnostics, Inc.

K number K120989

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NBW 2013-04-17

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION

Applicant Agamatrix, Inc.

K number K130535

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NBW 2013-04-12

IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM

Applicant Andon Medical Co., Ltd.

K number K123935

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NBW 2013-04-05

FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001

Applicant Abbott Laboratories

K number K123089

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NBW 2013-04-05

DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant Biocare Corporation

K number K122307

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NBW 2013-03-15

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM

Applicant Roche Diagnostics Corp.

K number K130138

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NBW 2013-03-07

GENESIS HEALTH RECORD SYSTEM, (GHRS)

Applicant Genesis Health Technologies

K number K123136

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NBW 2013-02-12

ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

Applicant Roche Diagnostics

K number K113614

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NBW 2013-02-11

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

Applicant Ceragem Medisys, Inc.

K number K102751

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NBW 2013-02-07

ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM

Applicant Cilag GmbH International

K number K120708

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NBW 2013-02-07

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION

Applicant Lifescan, Inc.

K number K120558

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NBW 2013-01-25

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN

Applicant Bionime Corporation

K number K123008

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NBW 2012-12-21

GLOOKO LOGBOOK CHARTS

Applicant Glooko, Inc.

K number K122142

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NBW 2012-12-14

ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM

Applicant ACON Laboratories, Inc.

K number K123010

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NBW 2012-12-11

DA01 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Delbio Incorporation

K number K120866

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NBW 2012-12-07

BLOOD GLUCOSE MONITORING SYSTEM

Applicant Andon Medical Co., Ltd.

K number K120813

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NBW 2012-11-30

GENSTRIP TEST STRIP MODEL 100-201

Applicant Shasta Technologies, LLC

K number K103542

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NBW 2012-10-11

ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM

Applicant Roche Diagnostics

K number K121679

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NBW 2012-09-05

TEST, BLOOD GLUCOSE SYSTEM

Applicant Hmd Biomedical, Inc.

K number K120064

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NBW 2012-08-21

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM

Applicant Tyson Bioresearch, Inc.

K number K112916

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NBW 2012-08-03

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

Applicant Bionime Corporation

K number K120423

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NBW 2012-08-03

BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM

Applicant Taidoc Technology Corporation

K number K113077

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NBW 2012-07-13

HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K113192

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NBW 2012-07-10

CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM

Applicant I-Sens, Inc.

K number K121133

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NBW 2012-07-06

AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM

Applicant Apex BioTechnology Corp.

K number K120649

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NBW 2012-06-28

CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

Applicant Bayer Healthcare

K number K121087

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NBW 2012-05-25

HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM

Applicant Health & Life Co., Ltd.

K number K110074

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NBW 2012-05-11

ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM

Applicant Broadmaster Biotech Corperation

K number K120183

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NBW 2012-05-03

CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA

Applicant I-Sens, Inc.

K number K120351

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NBW 2012-03-29

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM

Applicant Abbott Diabetes Care, Inc.

K number K120568

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NBW 2012-03-29

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700

Applicant Bionime Corporation

K number K110737

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NBW 2012-03-13

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

Applicant Delbio Incorporation

K number K103329

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NBW 2012-03-09

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS

Applicant Nova Biomedical Corporation

K number K112638

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NBW 2012-02-28

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

Applicant Tianjin Empecs Medical Device Co., Ltd.

K number K111456

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NBW 2012-02-10

AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

Applicant Bestgen Biotech Corp.

K number K103044

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NBW 2012-02-08

DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM

Applicant Delbio Incorporation

K number K113343

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NBW 2012-02-06

FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM

Applicant Taidoc Technology Corporation

K number K111890

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NBW 2012-01-27

MICRODOT & MICRODOT XTRA

Applicant Cambridge Sensors Limited

K number K102383

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NBW 2012-01-18

AG-608N BLOOD GLUCOSE MONITORING SYSTEM

Applicant Andon Medical Co., Ltd.

K number K110017

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NBW 2012-01-17

AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III

Applicant Apex BioTechnology Corp.

K number K113098

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NBW 2012-01-12

AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION

Applicant Bestgen Biotech Corp.

K number K100437

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NBW 2012-01-06

GLUCOSE TEST SYSTEM

Applicant Roche Diagnostics

K number K113137

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NBW 2011-12-20

FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM

Applicant Taidoc Technology Corporation

K number K101926

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NBW 2011-12-15

FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Taidoc Technology Corporation

K number K112275

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NBW 2011-12-07

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D

Applicant Agamatrix, Inc.

K number K103544

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NBW 2011-11-22

TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS

Applicant Taidoc Technology Corporation

K number K112963

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NBW 2011-11-10

IGLUCOSE SYSTEM

Applicant Positiveid Corporation

K number K111932

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NBW 2011-11-09

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE

Applicant Sweetspot Diabetes Care, Inc.

K number K111509

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NBW 2011-11-04

ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K103021

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