510(k) DEN240020
- Device
- Visby Medical Women's Sexual Health Test
- Applicant
- Visby Medical, Inc.
- 510(k) number
- DEN240020
- Product code
- SEA
- Decision
- Unknown (DENG)
- Decision date
- 2025-03-28
- Date received
- 2024-05-13
- Regulation
- 866.3386
- Classification name
- Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jennifer Albrecht
- Address
- 3010 N. First St. San Jose CA US 95134 95134
Source Documents#
510(k) summary PDF not indicated by FDA