510(k) K101037

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 by Eps Bio Technology Corp. — Product Code LFR

K101037 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017". The FDA issued a decision of Substantially Equivalent on May 23, 2011. The device falls under product code LFR (Glucose Dehydrogenase, 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.