510(k) K891094

ACA(R) DIGITOXIN (DGTX) METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code LFM

K891094 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA(R) DIGITOXIN (DGTX) METHOD". The FDA issued a decision of Substantially Equivalent on April 26, 1989. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.