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

System, Test, Blood Glucose, Over The Counter

Regulation 862.1345

6510(k)s in 12 months (514 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
Aug 9, 2005K051802FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW
Aug 8, 2005K051936CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
Taidoc Technology Corporation, TW
NBW
Aug 5, 2005K051854CLEVER CHEK TD-4225, MODEL TD-4225
Taidoc Technology Corporation, TW
NBW
Jul 13, 2005K0502243TEST GLUCOSE MONITORING SYSTEM
Neuero Engineering, Inc., TW
NBW
Jul 12, 2005K051147SIDEKICK BLOOD GLUCOSE TEST SYSTEM
Home Diagnostics, Inc.
NBW
Jun 27, 2005K050500FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW
Jun 2, 2005K043340EZ SMART
Vip Diagnostics, LLC
NBW
May 27, 2005K051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
Abbott Laboratories, Inc.
NBW
Apr 8, 2005K043543BLOOD GLUCOSE MONITORING SYSTEM
American Healthcare, Inc.
NBW
Mar 7, 2005K042795CLEVER CHEK TD-3213
Taidoc Technology Corporation, TW
NBW
Jan 3, 2005K042678RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Bionime Corporation
NBW
Dec 22, 2004K043311ASCENSIA ELITE DIABETES CARE SYSTEM
Bayer Healthcare, LLC
NBW
Dec 22, 2004K043158ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
Bayer Healthcare, LLC
NBW
Aug 27, 2004K042005ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
Taidoc Technology Corporation, TW
NBW
Aug 11, 2004K040848EZ SMART
Vip International Wholesalers, Corp.
NBW
Jul 23, 2004K041750PTS PANELS CHOL+GLU TEST PANEL
Polymer Technology Systems, Inc.
NBW
Jul 14, 2004K040678EUSURE BLOOD GLUCOSE MONITORING SYSTEM
Eumed Biotechnology Co., Ltd., TW
NBW
Jun 18, 2004K041107TAIDOC CHECK
Taidoc Technology Corporation, TW
NBW
May 19, 2004K040603PARADIGM LINK BLOOD GLUCOSE METER
Becton, Dickinson & CO
NBW
Apr 15, 2004K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
Abbott Laboratories
NBW
Mar 25, 2004K040670MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
Home Diagnostics, Inc.
NBW
Mar 25, 2004K040628PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
Abbott Laboratories
NBW
Mar 24, 2004K032657TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
Home Diagnostics, Inc.
NBW
Jan 8, 2004K033845PRECISION XCEED DIABETES MONITORING SYSTEM
Abbott Laboratories
NBW
Dec 19, 2003K031260FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
Abbott Diabetes Care, Inc.
NBW
Dec 18, 2003K032029BTG SMARTEST GLUCOSE TEST SYSTEM
Bt Medical, TW
NBW
Oct 21, 2003K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
Hmd Biomedical, Inc.
NBW
Oct 16, 2003K031501EASYGLUCO, MODEL IGM0002
American Healthcare, Inc.
NBW
Sep 12, 2003K032552ACCU-CHEK ADVANTAGE SYSTEM
Roche Diagnostics Corp.
NBW
Aug 4, 2003K023279GLUCOLEADER VALUE
Hmd Biomedical, Inc.
NBW
Jul 11, 2003K030703TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
Home Diagnostics, Inc.
NBW
Jul 3, 2003K031843MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
Medline Industries, Inc.
NBW
Apr 23, 2003K023256PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
Abbott Laboratories
NBW
Feb 7, 2003K024194ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
Lifescan, Inc.
NBW
Jan 23, 2003K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
Bayer Corp.
NBW
Dec 13, 2002K023832SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Dec 6, 2002K023219BECTON DICKINSON DIABETES SOFTWARE
Becton, Dickinson & CO
NBW
Nov 20, 2002K023584ASCENSIA DEX 2 DIABETES CARE SYSTEM
Bayer Corp.
NBW
Oct 11, 2002K022545GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
Hypoguard USA, Inc.
NBW
Oct 9, 2002K022581BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
Becton, Dickinson & CO
NBW
Sep 12, 2002K022724SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Sep 9, 2002K022182MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
Abbott Laboratories
NBW
Aug 23, 2002K021819ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Jul 23, 2002K022171ACCU-CHEK COMPACT SYSTEM
Roche Diagnostics Corp.
NBW
Jul 3, 2002K021827MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Roche Diagnostics Corp.
NBW
Jun 11, 2002K021513ACCU-CHEK ADVANTAGE MODULE
Roche Diagnostics Corp.
NBW
Jun 11, 2002K020866FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
Abbott Diabetes Care, Inc.
NBW
Jun 3, 2002K021448MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Roche Diagnostics Corp.
NBW
Apr 30, 2002K020210GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
Bayer Group Diagnostics
NBW
Apr 29, 2002K020208GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
Bayer Group Diagnostics
NBW

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