510(k) K221355

VITROS Immuodiagnostic Products CA 125 II Reagent Pack by Ortho Clinical Diagnostics — Product Code LTK

K221355 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immuodiagnostic Products CA 125 II Reagent Pack". The FDA issued a decision of Substantially Equivalent on December 12, 2022. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.