510(k) K080874

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT by Medica Corp. — Product Code CIX

K080874 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT". The FDA issued a decision of Substantially Equivalent on February 20, 2009. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Medica Corp. has at least 10 other 510(k) clearances on record.