510(k) K951851

ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY by E.I. Dupont DE Nemours & Co., Inc. — Product Code LJO

K951851 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on July 24, 1996. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.