K-number	K181853
Device name	Alere BinaxNOW Influenza A & B Card 2, Alere Reader
Applicant	Alere Scarborough, Inc.
Product code	PSZ
Device class	Class II
Decision date	Aug 8, 2018
Decision	Substantially Equivalent
Regulation	866.3328

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View the full FDA submission: accessdata.fda.gov

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Alere BinaxNOW Influenza A & B Card 2, Alere Reader

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