510(k) K113139

LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS by Lin-Zhi International, Inc. — Product Code DIO

K113139 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS". The FDA issued a decision of Substantially Equivalent on November 22, 2011. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.