510(k) K950137

URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DIS

K950137 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on April 13, 1995. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.