LFR — Glucose Dehydrogenase, Glucose

Class 2

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (73)

Device Name	Manufacturer	K-Number	Decision Date
FreeStyle InsuLinx Blood Glucose Monotioring System	Abott Laboratories	K152328	2015-09-17
ACCU-CHEK AVIVA EXPERT SYSTEM	Roche Diagnostics Corporation	K142089	2014-12-17
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	K133537	2014-04-28
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM	Ceragem Medisys, Inc.	K131727	2014-02-28
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM	Roche Diagnostics Operations, Inc.	K131366	2013-10-11
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR	Nova Biomedical Corporation	K122688	2013-04-04
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS	Hmd Biomedical, Inc.	K121433	2013-02-14
NOVA ONE BLOOD GLUCOSE MONITOR	Nova Biomedical Corporation	K122435	2012-12-20
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM	Hmd Biomedical, Inc.	K113314	2012-11-09
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	K121224	2012-09-19
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM	Hmd Biomedical, Inc.	K113307	2012-07-27
CONTOUR NEXT BLOOD GLUCOSE METER	Bayer Healthcare, LLC	K121190	2012-07-26
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	K120042	2012-05-22
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	K121207	2012-05-18
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	K113768	2012-04-12
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)	Bayer Healthcare, LLC	K110587	2012-03-28
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	K113243	2012-03-28
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	Bayer Healthcare	K110894	2012-03-28
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	Bayer Healthcare	K111268	2012-03-06
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS	Abbott Laboratories	K111874	2012-02-16

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