510(k) K011962

ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST by Advantage Diagnostics Corp. — Product Code DIO

K011962 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST". The FDA issued a decision of Substantially Equivalent on August 9, 2001. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.