Medical Device Manufacturer · US , Flagstaff , AZ

Eps Bio Technology Corp.

24 submissions · 24 cleared · Since 2005
24
Total
24
Cleared
0
Denied

Eps Bio Technology Corp. — FDA 510(k) Submissions

Eps Bio Technology Corp. has submitted 24 FDA 510(k) premarket notifications since 2005, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Glucose Dehydrogenase, Glucose, Glucose Oxidase, Glucose . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · NBW System, Test, Blood... · Chemistry
Sep 2021 478d
MDT2 BLE Self-Monitoring Blood Glucose System
K190189 · NBW System, Test, Blood... · Chemistry
Nov 2019 273d
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · NBW System, Test, Blood... · Chemistry
Aug 2018 24d
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
K133537 · LFR Glucose Dehydrogenase,... · Chemistry
Apr 2014 161d
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
K133389 · NBW System, Test, Blood... · Chemistry
Apr 2014 161d
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
K133647 · NBW System, Test, Blood... · Chemistry
Feb 2014 92d
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K121207 · LFR Glucose Dehydrogenase,... · Chemistry
May 2012 28d
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · LFR Glucose Dehydrogenase,... · Chemistry
Mar 2012 147d
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112901 · LFR Glucose Dehydrogenase,... · Chemistry
Dec 2011 81d
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K111728 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2011 88d
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112272 · LFR Glucose Dehydrogenase,... · Chemistry
Sep 2011 30d
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
K102345 · NBW System, Test, Blood... · Chemistry
Jun 2011 306d
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
K101037 · LFR Glucose Dehydrogenase,... · Chemistry
May 2011 404d
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
K101457 · NBW System, Test, Blood... · Chemistry
Jul 2010 36d
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
K092894 · NBW System, Test, Blood... · Chemistry
Feb 2010 156d
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
K092887 · NBW System, Test, Blood... · Chemistry
Oct 2009 30d
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
K091481 · NBW System, Test, Blood... · Chemistry
Aug 2009 91d
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · NBW System, Test, Blood... · Chemistry
Jul 2009 95d
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
K081796 · NBW System, Test, Blood... · Chemistry
Jan 2009 212d
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
K083099 · NBW System, Test, Blood... · Chemistry
Jan 2009 88d
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2008 51d
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · NBW System, Test, Blood... · Chemistry
Dec 2007 333d
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
K061992 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2006 68d
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K043245 · CGA Glucose Oxidase, Glucose · Chemistry
Apr 2005 157d
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