510(k) K082121

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 by Eps Bio Technology Corp. — Product Code CGA

K082121 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005". The FDA issued a decision of Substantially Equivalent on September 17, 2008. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Eps Bio Technology Corp. has at least 10 other 510(k) clearances on record.