FDA Product Code LTK: Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Leading manufacturers include Ortho-Clinical Diagnostics and Beckman Coulter, Inc..
2
Total
2
Cleared
148d
Avg days
2022
Since
List of Test, Epithelial Ovarian Tumor-associated Antigen (ca125) devices cleared through 510(k)
2 devices
Cleared
May 10, 2024
Access OV Monitor
Beckman Coulter, Inc.
Immunology
80d
Cleared
Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho-Clinical Diagnostics
Immunology
216d
How to use this database
This page lists all FDA 510(k) submissions for Test, Epithelial Ovarian Tumor-associated Antigen (ca125) devices (product code LTK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →