510(k) K905861

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

K905861 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH". The FDA issued a decision of Substantially Equivalent on February 6, 1991. 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.