K-number	K182001
Device name	Acucy Influenza A&B Test with the Acucy System
Applicant	SEKISUI Diagnostics, LLC
Product code	PSZ
Device class	Class II
Decision date	Dec 17, 2018
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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Acucy Influenza A&B Test with the Acucy System

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