LTK
- 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)
- 26
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240479 | 2024-05-10 | Beckman Coulter, Inc. | Access OV Monitor | FDA |
Official FDA classification page: LTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).