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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 4, 2019K190579TD-4183 Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
Jun 2, 2019K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
Bionime Corporation, TW
NBW
May 8, 2019K182428GlucoLeader Enhance Blood Glucose Monitoring System
Hmd Biomedical, Inc., TW
NBW
Apr 10, 2019K183306GLUCOCARD® W onyx Blood Glucose Monitoring System
Arkray Factory, Inc., JP
NBW
Feb 1, 2019K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
Andon Health Co, Ltd., CN
NBW
Dec 19, 2018K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Soun
Vivachek Laboratories, Inc.
NBW
Dec 13, 2018K181131Accu-Chek Guide Me Blood Glucose Monitoring System
Roche Diabetes Care
NBW
Nov 30, 2018K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
Tyson Bioresearch, Inc., TW
NBW
Nov 30, 2018K181588POPS! one Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
Nov 29, 2018K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
Tyson Bioresearch, Inc., TW
NBW
Nov 28, 2018K182992BGM014 Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
NBW
Nov 1, 2018K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Oct 3, 2018K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
ACON Laboratories, Inc.
NBW
Sep 19, 2018K182286Oh'Care Lite Smart Blood Glucose Monitoring System
Osang Healthcare Co. , Ltd., KR
NBW
Aug 31, 2018K180866CareSens S Fit Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Aug 24, 2018K182057EasyMax BT Self-Monitoring Blood Glucose System
Eps Bio Technology Corp., TW
NBW
Aug 21, 2018K173658Confidence Blood Glucose Monitoring System
Applied Biomedical, LLC
NBW
Aug 17, 2018K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monito
Bionime Corporation, TW
NBW
Aug 9, 2018K173505FORA GTel Blood Glucose Monitoring System
Foracare, Inc.
NBW
Jul 12, 2018K173511ActiveCare TD-4121 Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
Jun 19, 2018K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
Bionime Corporation, TW
NBW
Jun 14, 2018K181316POGO Automatic Blood Glucose Monitoring System
Intuity Medical, Inc.
NBW
Mar 23, 2018K172723Dario LC Blood Glucose Monitoring System
Labstyle Innovation, Ltd., IL
NBW
Mar 7, 2018K180196On Call Express Mobile Blood Glucose Monitoring System
ACON Laboratories, Inc.
NBW
Dec 13, 2017K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Nov 7, 2017K170464StatStrip Xpress Blood Glucose Monitoring System
Nova Biomedical Corporation
NBW
Nov 2, 2017K163087PixoTest Blood Glucose Monitoring System
Ixensor Company , Ltd., TW
NBW
Oct 19, 2017K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Oct 17, 2017K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Hom
Sd Biosensor, KR
NBW
Oct 13, 2017K170241GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Mo
All Medicus Co., Ltd., KR
NBW
Oct 6, 2017K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
Tyson Bioresearch, Inc., TW
NBW
Oct 5, 2017K170264Gold AQ Blood Glucose Monitoring System
Changsha Sinocare, Inc., CN
NBW
Sep 27, 2017K171941FreeStyle Precision Neo Blood Glucose Test Strips
Abbott Diabetes Care, Inc.
NBW
Sep 20, 2017K171822NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
Biotest Medical Corporation, TW
NBW
Sep 15, 2017K171785WowGoHealth Blood Glucose Monitoring System
Biotest Medical Corporation, TW
NBW
Sep 15, 2017K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
Andon Health Co, Ltd., CN
NBW
Aug 16, 2017K170064GLUCOCARD W Blood Glucose Monitoring System
Arkray Factory, Inc., JP
NBW
Jul 19, 2017K163159Dario Blood Glucose Monitoring System
Labstyle Innovations, Ltd., IL
NBW
Jul 6, 2017K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System
Bionime Corporation, TW
NBW
Jun 7, 2017K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucos
Tianjin Empecs Medical Device Co., Ltd., CN
NBW
May 2, 2017K161790iGlucose Blood Glucose Monitoring System
Bionime Corporation, TW
NBW
Apr 21, 2017K160179VivaChek Ino Blood Glucose Monitoring System
Vivachek Laboratories, Inc.
NBW
Apr 14, 2017K162382Smart Dongle Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
Apr 6, 2017K162203POGO Automatic Blood Glucose Monitoring System
Intuity Medical, Inc.
NBW
Mar 21, 2017K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200
Tianjin Empecs Medical Device Co., Ltd., CN
NBW
Mar 9, 2017K170267BGM009 Plus Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
NBW
Feb 16, 2017K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
Andon Health Co, Ltd., CN
NBW
Jan 19, 2017K162430UniStrip1 Generic Blood Glucose Test Strips
Ok Biotech Co., Ltd., TW
NBW
Jan 12, 2017K162336Contour Next EZ Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Dec 23, 2016K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
NBW

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