FDA Product Code LTK: Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Leading manufacturers include Ortho-Clinical Diagnostics and Beckman Coulter, Inc..
26
Total
26
Cleared
209d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Test, Epithelial Ovarian Tumor-associated Antigen (ca125) Devices (Product Code LTK)
26 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
About Product Code LTK - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code LTK since 1997, with 26 receiving FDA clearance (average review time: 209 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
LTK devices are reviewed by the Immunology panel. Browse all Immunology devices →