Visby Medical Flu and COVID-19 Test
FDA 510(k) clearance K253971 · decided 2026-05-27
Clearance details
- K-number
- K253971
- Device name
- Visby Medical Flu and COVID-19 Test
- Applicant
- Visby Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-11
- Decision date
- 2026-05-27
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- SIA
- Device class
- 2
- Regulation number
- 866.3984
- 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.