K253971
- 510(k) number
- K253971
- Device name
- Visby Medical Flu and COVID-19 Test
- Applicant
- Visby Medical, Inc. CA · US
- Product code
- SIA — Over-The-Counter Molecular Multi-Analyte Respiratory
- Decision date
- 2026-05-27
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253971.pdf
Official FDA record: K253971
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.