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
Jul 15, 2013K130657LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
All Medicus Co., Ltd.
NBW
Jun 28, 2013K123559SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
Biotest Medical Corp., TW
NBW
Jun 27, 2013K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Abbott Diabetes Care
NBW
Jun 21, 2013K130295LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
Infopia Co, Ltd.
NBW
Jun 19, 2013K123007VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
Mico Biomed Co., Ltd., KR
NBW
Jun 18, 2013K123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Jun 18, 2013K123016VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
Mico Biomed Co., Ltd., KR
NBW
May 16, 2013K124040FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
May 2, 2013K122525SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
Biotest Medical Corp., TW
NBW
Apr 25, 2013K130886GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
Glooko, Inc.
NBW
Apr 24, 2013K120989TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Nipro Diagnostics, Inc.
NBW
Apr 17, 2013K130535IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
Agamatrix, Inc.
NBW
Apr 12, 2013K123935IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Andon Medical Co., Ltd., CN
NBW
Apr 5, 2013K123089FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
Abbott Laboratories
NBW
Apr 5, 2013K122307DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
Biocare Corporation, TW
NBW
Mar 15, 2013K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
Roche Diagnostics Corp.
NBW
Mar 7, 2013K123136GENESIS HEALTH RECORD SYSTEM, (GHRS)
Genesis Health Technologies
NBW
Feb 12, 2013K113614ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics
NBW
Feb 11, 2013K102751LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
Ceragem Medisys, Inc.
NBW
Feb 7, 2013K120708ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
Cilag GmbH International
NBW
Feb 7, 2013K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
Lifescan, Inc.
NBW
Jan 25, 2013K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
Bionime Corporation
NBW
Dec 21, 2012K122142GLOOKO LOGBOOK CHARTS
Glooko, Inc.
NBW
Dec 14, 2012K123010ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
ACON Laboratories, Inc.
NBW
Dec 11, 2012K120866DA01 BLOOD GLUCOSE MONITORING SYSTEM
Delbio Incorporation, TW
NBW
Dec 7, 2012K120813BLOOD GLUCOSE MONITORING SYSTEM
Andon Medical Co., Ltd., CN
NBW
Nov 30, 2012K103542GENSTRIP TEST STRIP MODEL 100-201
Shasta Technologies, LLC
NBW
Oct 11, 2012K121679ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics
NBW
Sep 5, 2012K120064TEST, BLOOD GLUCOSE SYSTEM
Hmd Biomedical, Inc., TW
NBW
Aug 21, 2012K112916TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
Tyson Bioresearch, Inc., TW
NBW
Aug 3, 2012K120423BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
Bionime Corporation
NBW
Aug 3, 2012K113077BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Jul 13, 2012K113192HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Jul 10, 2012K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
I-Sens, Inc., KR
NBW
Jul 6, 2012K120649AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp., TW
NBW
Jun 28, 2012K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
Bayer Healthcare
NBW
May 25, 2012K110074HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
Health & Life Co., Ltd., TW
NBW
May 11, 2012K120183ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
Broadmaster Biotech Corperation, TW
NBW
May 3, 2012K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
I-Sens, Inc., KR
NBW
Mar 29, 2012K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW
Mar 29, 2012K110737RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
Bionime Corporation
NBW
Mar 13, 2012K103329DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
Delbio Incorporation, TW
NBW
Mar 9, 2012K112638NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
Nova Biomedical Corporation
NBW
Feb 28, 2012K111456MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
Tianjin Empecs Medical Device Co., Ltd., KR
NBW
Feb 10, 2012K103044AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
Bestgen Biotech Corp., TW
NBW
Feb 8, 2012K113343DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
Delbio Incorporation, TW
NBW
Feb 6, 2012K111890FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Jan 27, 2012K102383MICRODOT & MICRODOT XTRA
Cambridge Sensors Limited, GB
NBW
Jan 18, 2012K110017AG-608N BLOOD GLUCOSE MONITORING SYSTEM
Andon Medical Co., Ltd., CN
NBW
Jan 17, 2012K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
Apex BioTechnology Corp., TW
NBW

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