510(k) K983803

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

K983803 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE". The FDA issued a decision of Substantially Equivalent on December 14, 1998. 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.