510(k) K101089

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR by Medica Corp. — Product Code DCF

K101089 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on July 13, 2011. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Medica Corp. has at least 10 other 510(k) clearances on record.