510(k) K130080

EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL by Medica Corporation — Product Code JHY

K130080 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL". The FDA issued a decision of Substantially Equivalent on May 13, 2014. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Medica Corporation has at least 6 other 510(k) clearances on record.