510(k) K101742

THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY by Microgenics Corp. — Product Code DIO

K101742 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Microgenics Corp. has at least 10 other 510(k) clearances on record.