510(k) K241427

Access Syphilis by Beckman Coulter, Inc. — Product Code LIP

K241427 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Syphilis". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.