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
Dec 16, 2016K160742NoCoding1 Plus Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Nov 30, 2016K161834One Drop Blood Glucose Monitoring System
Agamatrix, Inc.
NBW
Nov 17, 2016K160682CONTOUR NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care
NBW
Nov 10, 2016K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
Taidoc Technology Corporation, TW
NBW
Sep 28, 2016K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
Infopia Co, Ltd., KR
NBW
Aug 31, 2016K160944ACCU-CHEK Guide Blood Glucose Monitoring System
Roche Diabetes Care, Inc.
NBW
Aug 19, 2016K153286iHealth Align Gluco-Monitoring system
Andon Health Co, Ltd., CN
NBW
Aug 19, 2016K153278Wireless Smart Gluco-Monitoring System
Andon Health Co, Ltd., CN
NBW
Aug 5, 2016K161867On Call Pro Blood Glucose Monitoring System
Acon Laboratories
NBW
Jul 29, 2016K160038UniStrip1 Generic Blood Glucose Test Strips
Ok Biotech Co., Ltd., TW
NBW
Jul 20, 2016K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
Ok Biotech Co., Ltd., TW
NBW
Jun 24, 2016K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Jun 24, 2016K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
Sd Biosensor, KR
NBW
Jun 23, 2016K160156StatStrip Xpress Blood Glucose Monitoring System
Nova Biomedical Corporation
NBW
Apr 25, 2016K152493POGO Automatic Blood Glucose Monitoring System
Intuity Medical, Inc.
NBW
Apr 21, 2016K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
Agamatrix, Inc.
NBW
Apr 1, 2016K143548TRUE METRIX GO Self Monitoring Blood Glucose System
Trividia Health, Inc.
NBW
Feb 19, 2016K153330FreeStyle Precision Neo H Blood Glucose Monitoring System
Abbott Diabetes Care, Inc.
NBW
Jan 8, 2016K143169MyGlucoHealth Wireless System
Entra Health Systems
NBW
Dec 21, 2015K150817Dario Blood Glucose Monitoring System
Labstyle Innovations, Ltd.
NBW
Dec 17, 2015K152442Freestyle Freedom Blood Glucose Monitoring Sytem
Abbott Laboratories
NBW
Dec 17, 2015K142785PRODIGY iConnect Blood Glucose Monitoring System
Ok Biotech Co., Ltd., TW
NBW
Dec 14, 2015K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring System
Lifescan Europe, CH
NBW
Dec 4, 2015K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart G
Andon Health Co, Ltd., CN
NBW
Dec 1, 2015K151658Gmate Origin Blood Glucose Monitoring System
Philosys, Inc.
NBW
Nov 25, 2015K150942Contour Next USB Blood Glucose Monitoring System
Bayer Healthcare
NBW
Nov 24, 2015K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
Sd Biosensor, KR
NBW
Nov 19, 2015K150299Gmate SMART Blood Glucose Monitoring System
Philosys, Inc.
NBW
Oct 14, 2015K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood
Apex BioTechnology Corp., CN
NBW
Oct 13, 2015K140325Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System
Joinsoon Medical Technology Co, Ltd.
NBW
Oct 2, 2015K141656GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
Philosys, Inc.
NBW
Sep 30, 2015K142928FreeStyle Precision Neo Blood Glucose Monitoring System
Abbott Diabetes Care, Inc.
NBW
Sep 29, 2015K151100U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
Sep 5, 2015K151595On Call Express Pro Blood Glucose Monitoring System
ACON Laboratories, Inc.
NBW
Aug 26, 2015K150274GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
Infopia Co, Ltd., KR
NBW
Aug 7, 2015K151164Assure Prism multi Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Aug 5, 2015K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SY
Sd Biosensor, Inc.
NBW
Jul 31, 2015K150214OneTouch Verio Flex Blood Glucose Monitoring System
Lifescan Europe, CH
NBW
Jun 9, 2015K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Moni
Bionime Coporation
NBW
Jun 5, 2015K150531FreeStyle Freedom Lite Blood Glucose Monitoring System
Abbott Laboratories
NBW
Jun 5, 2015K150332FreeStyle Lite Blood Glucose Monitoring System
Abbott Laboratories
NBW
Jun 3, 2015K143387GE333 Blood Glucose Monitoring System
Bionime Coporation, TW
NBW
May 22, 2015K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
Polymer Technology Systems, Inc.
NBW
May 19, 2015K141351SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
Biotest Medical Corp., TW
NBW
May 14, 2015K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood
Hmd Biomedical, Inc., TW
NBW
May 7, 2015K143467FORA GD43 Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
NBW
May 1, 2015K141036BGM009 BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp., TW
NBW
Apr 20, 2015K132663I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
Alliance International Co., Ltd., TW
NBW
Apr 15, 2015K141914PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
Ok Biotech Co., Ltd., TW
NBW
Mar 26, 2015K150052TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
Nipro Diagnostics, Inc.
NBW

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