510(k) K211302

Elecsys Syphilis by Roche Diagnostics — Product Code LIP

K211302 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Syphilis". The FDA issued a decision of Substantially Equivalent on July 20, 2021. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Roche Diagnostics has at least 10 other 510(k) clearances on record.