510(k) K983805

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

K983805 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO". The FDA issued a decision of Substantially Equivalent on May 26, 1999. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.