K240479
- 510(k) number
- K240479
- Device name
- Access OV Monitor
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (C
- Decision date
- 2024-05-10
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
510(k) Summary (official FDA PDF): K240479.pdf
Official FDA record: K240479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.