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
Jun 22, 2007K070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
Cambridge Sensors Limited, GB
NBW
Jun 21, 2007K070941CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
Taidoc Technology Corporation, TW
NBW
Jun 13, 2007K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
Nova Biomedical Corp.
NBW
May 25, 2007K070585ACCU-CHEK PERFORMA SYSTEM
Roche Diagnostics Corp.
NBW
May 25, 2007K070239MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
Exir Pharmaceutical Co., TW
NBW
May 9, 2007K062395ACCU-CHEK SMART PIX
Roche Diagnostics Corp.
NBW
May 7, 2007K070593TRACKRECORD DATA MANAGEMENT SOFTWARE
Home Diagnostics, Inc.
NBW
Apr 30, 2007K062538EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
Diacare Corp.
NBW
Apr 10, 2007K070850FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW
Apr 9, 2007K070641ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
Taidoc Technology Corporation, TW
NBW
Mar 15, 2007K070472CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
Taidoc Technology Corporation, TW
NBW
Feb 16, 2007K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp., TW
NBW
Feb 16, 2007K062567RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Bionime Corporation
NBW
Feb 9, 2007K063026OK METER BLOOD GLUCOSE MONITORING SYSTEM
Ok Biotech Co., Ltd., TW
NBW
Jan 31, 2007K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
Polymer Technology Systems, Inc.
NBW
Jan 12, 2007K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
Agamatrix
NBW
Jan 12, 2007K062800CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
Taidoc Technology Corporation, TW
NBW
Dec 27, 2006K062555EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
Visgeneer, Inc., TW
NBW
Dec 20, 2006K063068FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
Arkray USA, Inc.
NBW
Dec 14, 2006K062770COPILOT HEALTH MANAGEMENT SYSTEM
Abbott Diabetes Care, Inc.
NBW
Nov 22, 2006K063212CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Nov 22, 2006K062347ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
Bayer Healthcare, LLC
NBW
Nov 13, 2006K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
Agamatrix
NBW
Oct 30, 2006K061234GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
Glucoplus, Inc.
NBW
Oct 10, 2006K062829DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Sep 19, 2006K062235EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
Taidoc Technology Corporation, TW
NBW
Sep 11, 2006K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
Bayer Healthcare
NBW
Aug 16, 2006K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Aug 11, 2006K060620ACCU-CHEK AVIVA TEST STRIPS
Roche Diagnostics Corp.
NBW
Jul 25, 2006K060793ELEMENT BLOOD GLUCOSE TEST SYSTEM
Home Diagnostics, Inc.
NBW
Jul 13, 2006K060467PRODIGY BLOOD GLUCOSE TEST SYSTEM
Diagnostic Devices, Inc.
NBW
Jul 6, 2006K061181ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
Taidoc Technology Corporation, TW
NBW
Jul 6, 2006K053593PRODIGY
Diagnostic Devices, Inc.
NBW
Jun 16, 2006K052818EZ SMART-168 GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc.
NBW
Jun 13, 2006K061328THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
E-San Limited
NBW
Jun 5, 2006K052469GLUCOPACK
Healthpia America Corp.
NBW
May 19, 2006K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Apr 14, 2006K051651G4, MODEL IGM-0004
U. S. Diagnostics, Inc.
NBW
Apr 12, 2006K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
Bayer Healthcare
NBW
Mar 9, 2006K051839FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
Abbott Diabetes Care, Inc.
NBW
Mar 1, 2006K053312EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
Bioptik Technology, Inc.
NBW
Feb 21, 2006K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Bionime Corporation
NBW
Jan 23, 2006K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
Agamatrix, Inc.
NBW
Jan 17, 2006K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Dec 9, 2005K052208GLUCOSE PILOT
Tianjin New Bay Bioresearch Co., Ltd.
NBW
Dec 7, 2005K052343E-SAN BLUETOOTH CRADLE
E-San Limited
NBW
Dec 7, 2005K052108SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
Sein Electronics Co., Ltd.
NBW
Oct 7, 2005K050985GLUCODR SUPERSENSOR SYSTEM
All Medicus Co., Ltd., KR
NBW
Oct 4, 2005K051514ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
Hypoguard USA, Inc.
NBW
Aug 9, 2005K051802FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW

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