K251501
- 510(k) number
- K251501
- Device name
- Visby Medical Men's Sexual Health Test
- Applicant
- Visby Medical, Inc. CA · US
- Product code
- QEP — Nucleic Acid Detection System For Non-Viral Microorg
- Decision date
- 2025-10-01
- Date received
- 2025-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251501.pdf
Official FDA record: K251501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.