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
Mar 3, 2015K141867ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics
NBW
Dec 2, 2014K141862HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
H2, Inc.
NBW
Sep 30, 2014K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
Abbott Diabetes Care, Inc.
NBW
Sep 24, 2014K141829GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
Ceragem Medisys, Inc., KR
NBW
Sep 18, 2014K131173FIA Blood Glucose Monitoring System (G2)
Hmd Biomedical, Inc., TW
NBW
Sep 5, 2014K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
Arkray Factory, Inc.
NBW
Aug 29, 2014K133741ACCU-CHEK Performa Blood Glucose Monitoring System
Roche Diagnostics
NBW
Aug 22, 2014K140210RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720
Bionime Corporation
NBW
Aug 14, 2014K132633OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
Ok Biotech Co., Ltd., TW
NBW
Aug 4, 2014K131230GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
Philosys, Inc.
NBW
Aug 1, 2014K140100TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Nipro Diagnostics, Inc.
NBW
Jul 3, 2014K140141LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
Ceragem Medisys, Inc., KR
NBW
Jun 27, 2014K133260MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM
Tianjin Empecs Medical Device Co., Ltd.
NBW
Jun 25, 2014K132180IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
Ideal Life, Inc.
NBW
Jun 23, 2014K130265CONTOUR NEXT EZ BLOOD GLUCOSE METER
Bayer Healthcare, LLC
NBW
May 22, 2014K133790IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
Andon Health Co, Ltd., CN
NBW
Apr 29, 2014K133862ACCU-CHEK AVIVA PLUS SYSTEM
Roche Diagnostics Corporation
NBW
Apr 18, 2014K132406ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Apr 17, 2014K133522RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
Bionime Coporation
NBW
Apr 15, 2014K133389EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
NBW
Apr 10, 2014K133045ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd., KR
NBW
Feb 27, 2014K133647EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
NBW
Feb 21, 2014K133509EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
Biotest Medical Corp.
NBW
Jan 17, 2014K123517GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
Sd Biosensor
NBW
Jan 6, 2014K131469ACON ON CALL DIABETES MANAGEMENT SOFTWARE
ACON Laboratories, Inc.
NBW
Dec 24, 2013K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
NBW
Dec 20, 2013K130284ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
ACON Laboratories, Inc.
NBW
Dec 19, 2013K133346SMARTLOG DIABETES MANAGEMENT SOFTWARE
I-Sens, Inc., KR
NBW
Dec 19, 2013K132086ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
ACON Laboratories, Inc.
NBW
Dec 12, 2013K132862HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Dec 5, 2013K132966GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Nov 26, 2013K122340PRODIGY CHOICE
Prodigy Diabetes Care, LLC
NBW
Nov 22, 2013K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
I-Sens, Inc., KR
NBW
Nov 22, 2013K123090GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
General Life Biotechnology Co., Ltd.
NBW
Nov 20, 2013K132821AGAMATRIX HEALTH MANAGER
Agamatrix, Inc.
NBW
Nov 6, 2013K113135UNISTRIP 1
Unistrip Technologies, LLC
NBW
Nov 5, 2013K122338PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
Prodigy Diabetes Care, LLC
NBW
Oct 24, 2013K132338DA01 BLOOD GLUCOSE MONITORING SYSTEM
Delbio Incorporation, TW
NBW
Oct 17, 2013K132272GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
Glooko, Inc.
NBW
Oct 17, 2013K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
Nova Biomedical Corporation
NBW
Sep 26, 2013K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
Bayer Healthcare
NBW
Aug 30, 2013K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
Cilag GmbH International, CH
NBW
Aug 23, 2013K130244DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
Delbio Incorporation, TW
NBW
Aug 21, 2013K130696CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
I-Sens, Inc., KR
NBW
Aug 15, 2013K132072TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Nipro Diagnostics, Inc.
NBW
Aug 15, 2013K122181EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
Visgeneer, Inc., TW
NBW
Aug 9, 2013K131419ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
I-Sens, Inc., KR
NBW
Aug 9, 2013K131029ACCU-CHEK AVIVA PLUS TEST STRIP
Roche Diagnostics Operations, Inc.
NBW
Jul 31, 2013K130181GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
NBW
Jul 30, 2013K130621BROADMASTER HEALTHCARE SYSTEM
Broadmaster Biotech Corporation, TW
NBW

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