510(k) K111036

EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT by Medica Corporation — Product Code LBS

K111036 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT". The FDA issued a decision of Substantially Equivalent on July 12, 2011. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Medica Corporation has at least 6 other 510(k) clearances on record.