510(k) K993796

RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE by American Bio Medica Corp. — Product Code LDJ

K993796 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.