K-number	K231795
Device name	QuickVue COVID-19 Test
Applicant	Quidel Corporation
Product code	QYT
Device class	Class II
Decision date	Mar 22, 2024
Decision	Substantially Equivalent
Regulation	866.3984

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Source

View the full FDA submission: accessdata.fda.gov

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QuickVue COVID-19 Test

Everything you need for a 510(k) submission. Nothing you don't.