K-number	K230828
Device name	Flowflex COVID-19 Antigen Home Test
Applicant	ACON Laboratories, Inc.
Product code	QYT
Device class	Class II
Decision date	Nov 9, 2023
Decision	Substantially Equivalent
Regulation	866.3984

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View the full FDA submission: accessdata.fda.gov

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Flowflex COVID-19 Antigen Home Test

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