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

Name: FDA 510(k) clearance K253971
Creator: U.S. Food and Drug Administration
Published: 2026-05-27

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.. Device class: 2.

Clearance details

Applicant: Visby Medical, Inc.
Product code: Code SIA
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2025-12-11
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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