DEN240020
- 510(k) number
- DEN240020
- Device name
- Visby Medical Women's Sexual Health Test
- Applicant
- Visby Medical, Inc. CA · US
- Product code
- SEA — Test For Detection Of Microorganism(S) Causing Sexua
- Decision date
- 2025-03-28
- Date received
- 2024-05-13
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN240020
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.