K-number	K192719
Device name	Osom Ultra Plus Flu A&B Test Kit
Applicant	SEKISUI Diagnostics, LLC
Product code	PSZ
Device class	Class II
Decision date	Apr 3, 2020
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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Osom Ultra Plus Flu A&B Test Kit

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