K-number	K141520
Device name	ALERE I INFLUENZA A & B
Applicant	Alere Scarborough, Inc D/B/A Binax, Inc.
Product code	OCC
Device class	Class II
Decision date	Jun 13, 2014
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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ALERE I INFLUENZA A & B

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