510(k) K080436

RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 by Quantrx Biomedical Corporation — Product Code DIO

K080436 is an FDA 510(k) premarket notification submitted by Quantrx Biomedical Corporation for the device "RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052". The FDA issued a decision of Substantially Equivalent on February 11, 2009. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Quantrx Biomedical Corporation has at least 3 other 510(k) clearances on record.