Name: Predicase
Price: 199 USD

K-number	K032166
Device name	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
Applicant	Binax, Inc.
Product code	GQG
Device class	Class I
Decision date	Oct 21, 2003
Decision	Substantially Equivalent
Regulation	866.3480

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Source

View the full FDA submission: accessdata.fda.gov

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BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

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