510(k) K191638

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay by Medtest DX — Product Code DIO

K191638 is an FDA 510(k) premarket notification submitted by Medtest DX for the device "Pointe Scientific Cocaine Metabolite Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on March 12, 2020. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Medtest DX has at least 1 other 510(k) clearance on record.