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LTK

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Product code
LTK
Device name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class
Class 2
21 CFR
21 CFR 866.6010
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
26 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-10.

NumberDecision dateApplicantDevice nameSummary
K2404792024-05-10Beckman Coulter, Inc.Access OV MonitorFDA
Official FDA classification page: LTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).