510(k) K072249

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT by Medica Corp. — Product Code CHH

K072249 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT". The FDA issued a decision of Substantially Equivalent on February 20, 2008. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Medica Corp. has at least 10 other 510(k) clearances on record.