510(k) K053422

RAPIDONE-COCAINE-150 TEST by American Bio Medica Corp. — Product Code DIO

K053422 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDONE-COCAINE-150 TEST". The FDA issued a decision of Substantially Equivalent on June 15, 2006. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.