510(k) K012159

RAPID DRUG SCREEN by American Bio Medica Corp. — Product Code DKZ

K012159 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPID DRUG SCREEN". The FDA issued a decision of Substantially Equivalent on July 25, 2001. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.