510(k) K240670

DRI Ecstasy Plus Assay by Microgenics Corporation — Product Code DKZ

K240670 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "DRI Ecstasy Plus Assay". The FDA issued a decision of Substantially Equivalent on October 30, 2024. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Microgenics Corporation has at least 10 other 510(k) clearances on record.