510(k) K946153

DIGOXIN FLEX(TM) REAGENT CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code KXT

K946153 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DIGOXIN FLEX(TM) REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 22, 1995. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.