510(k) K984126

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

K984126 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.