510(k) K103363

ZEUS ELISA HSV GC-I IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code MXJ

K103363 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS ELISA HSV GC-I IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 2011. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.