510(k) K983656

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code LGC

K983656 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 18, 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.