K-number	K083744
Device name	BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
Applicant	Binax, Inc.
Product code	MJZ
Device class	Class I
Decision date	Sep 1, 2009
Decision	Substantially Equivalent
Regulation	862.1660

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BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

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