510(k) K231517

VITROS Immunodiagnostic Products CEA Reagent Pack by Ortho Clinical Diagnostics — Product Code DHX

K231517 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products CEA Reagent Pack". The FDA issued a decision of Substantially Equivalent on August 23, 2023. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.