ClearanceBrief
Panels › Clinical Chemistry › Product code NBW · Class 2

System, Test, Blood Glucose, Over The Counter

Regulation 862.1345

5510(k)s in 12 months (513 all time)
4recalls in 12 months (137 all time)
100recalls that name a 510(k)
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Top companies in NBW

Company510(k)sRecalls
Taidoc Technology Corporation650
Abbott Diabetes Care1922
Lifescan, Inc.1317
Roche Diagnostics198
I-Sens, Inc.220
Apex BioTechnology Corp.180
Bionime Corporation180
Roche Diabetes Care413
Nova Biomedical Corp.610
EPS Bio Technology Corp.150
Decided510(k)Device and applicantCode
Jan 12, 2012K100437AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
Bestgen Biotech Corp., TW
NBW
Jan 6, 2012K113137GLUCOSE TEST SYSTEM
Roche Diagnostics
NBW
Dec 20, 2011K101926FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Dec 15, 2011K112275FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Dec 7, 2011K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
Agamatrix, Inc.
NBW
Nov 22, 2011K112963TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Taidoc Technology Corporation, TW
NBW
Nov 10, 2011K111932IGLUCOSE SYSTEM
Positiveid Corporation
NBW
Nov 9, 2011K111509SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
Sweetspot Diabetes Care, Inc.
NBW
Nov 4, 2011K103021ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Oct 12, 2011K103115PRODIGY DIABETES MANAGEMENT SOFTWARE
Prodigy Diabetes Care, LLC
NBW
Oct 11, 2011K102063HEALTH-E-CONNECT SYSTEM
Alr Technologies
NBW
Sep 30, 2011K112738ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
Andon Medical Co., Ltd., CN
NBW
Sep 27, 2011K103396COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
I-Sens, Inc.
NBW
Sep 21, 2011K110435EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
U. S. Diagnostics, Inc.
NBW
Sep 16, 2011K100806DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
Delbio Incorporation, TW
NBW
Sep 15, 2011K102816GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
Apex BioTechnology Corp., TW
NBW
Sep 2, 2011K101631FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Aug 31, 2011K101635TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Aug 30, 2011K101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
Tyson Bioresearch, Inc., TW
NBW
Aug 26, 2011K102678ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Andon Medical Co., Ltd., CN
NBW
Aug 9, 2011K101307BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
Andon Medical Co., Ltd., CN
NBW
Jul 28, 2011K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
Telcare, Inc.
NBW
Jul 15, 2011K093755AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
Andon Medical Co., Ltd., CN
NBW
Jul 1, 2011K111029FORA POCT MANAGMENT SYSTEM
Taidoc Technology Corporation, TW
NBW
Jun 27, 2011K101509U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Jun 21, 2011K102345EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
Eps Bio Technology Corp., TW
NBW
May 27, 2011K102049CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
May 19, 2011K110709ARK CARE DIABETES MANAGMENT SYSTEM
Arkray Factory USA, Inc.
NBW
May 13, 2011K110948HEALTH CARE SYSTEM SOFTWARE
Taidoc Technology Corporation, TW
NBW
Apr 28, 2011K102481AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
Apex BioTechnology Corp., TW
NBW
Feb 11, 2011K093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Jan 7, 2011K101371ON CALL PLUS DIABETES MONITORING SOFTWARE
ACON Laboratories, Inc.
NBW
Dec 21, 2010K100937PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
I-Sens, Inc., KR
NBW
Oct 18, 2010K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
Agamatrix
NBW
Aug 13, 2010K092875ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
Taidoc Technology Corporation, TW
NBW
Jul 13, 2010K093262AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
Andon Medical Co., Ltd., CN
NBW
Jul 9, 2010K100732FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
Taidoc Technology Corporation, TW
NBW
Jul 1, 2010K101457EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
Eps Bio Technology Corp., TW
NBW
Jun 28, 2010K100322TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
Taidoc Technology Corporation, TW
NBW
Jun 18, 2010K092052RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
Bionime Corporation
NBW
Jun 15, 2010K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
Abbott Diabetes Care, Inc.
NBW
Jun 9, 2010K100398SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
Standard Diagnostics, Inc.
NBW
Jun 9, 2010K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
Arkray Factory USA, Inc.
NBW
May 27, 2010K091168GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
Infopia Co, Ltd.
NBW
May 14, 2010K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
Abbott Diabetes Care, Inc.
NBW
May 12, 2010K100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
Biotest Medical Corp., TW
NBW
May 5, 2010K094005FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Apr 23, 2010K093940ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
Taidoc Technology Corporation, TW
NBW
Apr 8, 2010K100701SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
Biotest Medical Corp., TW
NBW
Mar 15, 2010K091555MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW

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