510(k) K984133

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

K984133 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.