K-number	K152523
Device name	JBAIDS Influenza A & B Detection Kit
Applicant	U.S Army Medical Materiel Development Activity
Product code	OCC
Device class	Class II
Decision date	Oct 1, 2015
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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JBAIDS Influenza A & B Detection Kit

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