510(k) K871305

COCAINE METABOLITE ENZYME IMMUNOASSAY KIT by General Diagnostics — Product Code DIO

K871305 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "COCAINE METABOLITE ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. General Diagnostics has at least 10 other 510(k) clearances on record.