510(k) K102283

ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code LIP

K102283 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 10, 2011. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.