510(k) K984120

THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH by Zeus Scientific, Inc. — Product Code GQL

K984120 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH". The FDA issued a decision of Substantially Equivalent on May 26, 1999. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.