510(k) K950135

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

K950135 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 30, 1995. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.