510(k) K950134

URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLN

K950134 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code DLN (Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)), a Class II device regulated under 21 CFR 862.3250. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.