Visby Medical Flu and COVID-19 Test— 510(k) K253971

Substantially Equivalent

Visby Medical, Inc.

FDA 510(k) clearance K253971 for Visby Medical Flu and COVID-19 Test, Substantially Equivalent on 2026-05-27. Applicant: Visby Medical, Inc..

Clearance details

Applicant
Visby Medical, Inc.
Product code
Code SIA
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
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