510(k) K103603

ZEUS ELISA HSV GG-2 IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code MYF

K103603 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS ELISA HSV GG-2 IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2), a Class II device regulated under 21 CFR 866.3305. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.