QuickVue COVID-19 Test— 510(k) K231795

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K231795 for QuickVue COVID-19 Test, Substantially Equivalent on 2024-03-22. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2023-06-20
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
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Data sourced from openFDA. This site is unofficial and independent of the FDA.