510(k) K921455

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code CFE

K921455 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD". The FDA issued a decision of Substantially Equivalent on April 29, 1992. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.