510(k) K241534

VITROS Immunodiagnostic Products Syphilis Reagent Pack by Ortho Clinical Diagnostics — Product Code LIP

K241534 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products Syphilis Reagent Pack". The FDA issued a decision of Substantially Equivalent on August 28, 2024. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.