K-number	K123182
Device name	OSOM INFLUENZA A&B TEST MODEL 190
Applicant	SEKISUI Diagnostics, LLC
Product code	GNX
Device class	Class I
Decision date	Nov 5, 2012
Decision	Substantially Equivalent
Regulation	866.3330

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Source

View the full FDA submission: accessdata.fda.gov

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OSOM INFLUENZA A&B TEST MODEL 190

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