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Eps Bio Technology Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K201258EASYMAX Tag Self-Monitoring Blood Glucose SystemSeptember 1, 2021
K190189MDT2 BLE Self-Monitoring Blood Glucose SystemNovember 1, 2019
K182057EasyMax BT Self-Monitoring Blood Glucose SystemAugust 24, 2018
K133537EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEMApril 28, 2014
K133389EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEMApril 15, 2014
K133647EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEMFebruary 27, 2014
K121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMMay 18, 2012
K113243EM50 SELF MONITORING BLOOD GLUCOSE SYSTEMMarch 28, 2012
K112901EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEMDecember 23, 2011
K111728EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEMSeptember 16, 2011
K112272EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEMSeptember 7, 2011
K102345EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042June 21, 2011
K101037EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017May 23, 2011
K101457EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031July 1, 2010
K092894EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEMFebruary 24, 2010
K092887EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009October 21, 2009
K091481EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEMAugust 18, 2009
K091229GLUCOMANAGER DATA MANAGEMENT SOFTWAREJuly 31, 2009
K081796EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEMJanuary 23, 2009
K083099EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008January 16, 2009