510(k) K950427

URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code JXM

K950427 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.