510(k) K150502

DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls by Microgenics Corporation — Product Code DJG

K150502 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls". The FDA issued a decision of Substantially Equivalent on October 9, 2015. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Microgenics Corporation has at least 10 other 510(k) clearances on record.