510(k) K992166

THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR by Zeus Scientific, Inc. — Product Code LGC

K992166 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific), a Class II device regulated under 21 CFR 866.3305. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.