510(k) K013180

RAPIDONE-ECSTASY TEST by American Bio Medica Corp. — Product Code DJC

K013180 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDONE-ECSTASY TEST". The FDA issued a decision of Substantially Equivalent on November 26, 2001. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.