510(k) K984139

THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE by Zeus Scientific, Inc. — Product Code LFZ

K984139 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.