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 8, 2009K081703MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
Entra Health Systems, Ltd.
NBW
Dec 24, 2008K082020ENVISION BLOOD GLUCOSE TEST SYSTEM
Infopia Co, Ltd.
NBW
Dec 17, 2008K081715FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
Taidoc Technology Corporation, TW
NBW
Dec 4, 2008K082169PRO GLUCOSE TEST STRIP
Taidoc Technology Corporation, TW
NBW
Nov 26, 2008K081975RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
Abbott Diabetes Care, Inc.
NBW
Oct 22, 2008K082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Oct 17, 2008K080923CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
I-Sens, Inc., KR
NBW
Oct 8, 2008K082486GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
Bayer Healthcare, LLC
NBW
Oct 7, 2008K082618ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
Taidoc Technology Corporation, TW
NBW
Sep 18, 2008K081451RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
Bionime Corporation
NBW
Sep 11, 2008K081450RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
Bionime Corporation
NBW
Sep 5, 2008K080960PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
Abbott Diabetes Care, Inc.
NBW
Aug 26, 2008K081726TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Aug 19, 2008K080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
Home Diagnostics, Inc.
NBW
Aug 13, 2008K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
Home Diagnostics, Inc.
NBW
Aug 5, 2008K081957U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Jul 21, 2008K073030AG-605 BLOOD GLUCOSE MONITORING SYSTEM
Andon Health Co, Ltd., CN
NBW
Jul 15, 2008K081389ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics
NBW
Jul 3, 2008K080538IDEAL LIFE POD (MODEL ILP 0001)
Ideal Life, Inc.
NBW
Jun 30, 2008K072854DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Jun 27, 2008K080283IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Jun 23, 2008K081144CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
Taidoc Technology Corporation, TW
NBW
Jun 9, 2008K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
Lifescan, Inc.
NBW
Jun 9, 2008K080014CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Apr 21, 2008K080501SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
Taidoc Technology Corporation, TW
NBW
Apr 18, 2008K073231ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Apr 18, 2008K0729053TEST SUPREME GLUCOSE MONITORING SYSTEM
Neuero Engineering, Inc., TW
NBW
Apr 8, 2008K073492DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Apr 2, 2008K073494CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
Taidoc Technology Corporation, TW
NBW
Apr 1, 2008K073137GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
Apex BioTechnology Corp., TW
NBW
Mar 26, 2008K073699MCT-DIABETES
Mycare Team, Inc.
NBW
Mar 25, 2008K072441EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Mar 21, 2008K072369EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
Hmd Biomedical, LLC
NBW
Mar 5, 2008K073118PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
Diagnostic Devices, Inc., TW
NBW
Mar 3, 2008K073119CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Feb 29, 2008K072274MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
Bestgen Biotech Corp., TW
NBW
Feb 28, 2008K072054RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
Bionime Corporation
NBW
Jan 30, 2008K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
Agamatrix
NBW
Dec 21, 2007K072784PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Dec 3, 2007K070053EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
Eps Bio Technology Corp., TW
NBW
Oct 26, 2007K071493CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
Taidoc Technology Corporation, TW
NBW
Oct 5, 2007K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
NBW
Oct 3, 2007K072039ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F
Taidoc Technology Corporation, TW
NBW
Sep 27, 2007K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
Agamatrix
NBW
Sep 20, 2007K072489REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Sep 10, 2007K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
Polymer Technology Systems, Inc.
NBW
Aug 9, 2007K063771GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
Arkray Factory USA, Inc.
NBW
Jul 20, 2007K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEM
Agamatrix
NBW
Jul 3, 2007K062377MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
Medapps, Inc.
NBW
Jun 29, 2007K070559POLYMAP PWR-08-03
Polymap Wireless
NBW

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