DeviceClearance

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.. Device class: 2.

Summary

Visby Medical's Flu and COVID-19 Test is filed under SIA, over-the-counter molecular multi-analyte respiratory virus detection tests.

Class II, 21 CFR 866.3984. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).

Visby filed from San Jose, California. The decision came 167 calendar days after receipt (December 11, 2025 to May 27, 2026).

Clearance details

Applicant
Visby Medical, Inc.
Product code
Product code SIA
Device class
Class 2
Regulation
21 CFR 866.3984
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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