510(k) K101754

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY by Microgenics Corp. — Product Code DJG

K101754 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Microgenics Corp. has at least 10 other 510(k) clearances on record.