510(k) DEN240020
DEN240020 is an FDA 510(k) premarket notification submitted by Visby Medical, Inc. for the device "Visby Medical Women's Sexual Health Test". The FDA issued a decision of De Novo Granted on March 28, 2025. The device falls under product code SEA (Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users), a Class II device regulated under 21 CFR 866.3386. Visby Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 28, 2025
- Date Received
- May 13, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- Device Class
- Class II
- Regulation Number
- 866.3386
- Review Panel
- MI
- Submission Type
This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.