510(k) K101744

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY by Microgenics Corp. — Product Code LDJ

K101744 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Microgenics Corp. has at least 10 other 510(k) clearances on record.