Name: Predicase
Price: 199 USD

K-number	K151464
Device name	Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Applicant	Alere Scarborough, Inc.
Product code	OCC
Device class	Class II
Decision date	Jul 28, 2015
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, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

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