Visby Medical Women's Sexual Health Test
FDA 510(k) clearance DEN240020 · decided 2025-03-28
Clearance details
- K-number
- DEN240020
- Device name
- Visby Medical Women's Sexual Health Test
- Applicant
- Visby Medical, Inc.
- Decision
- Unknown
- Date received
- 2024-05-13
- Decision date
- 2025-03-28
- Days to decision
- 319 days
- Clearance type
- Direct
- Product code
- SEA
- Device class
- 2
- Regulation number
- 866.3386
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.