Name: Predicase
Price: 199 USD

K-number	K021649
Device name	BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Applicant	Binax, Inc.
Product code	PSZ
Device class	Class II
Decision date	Sep 19, 2002
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

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