BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX (DEN070006) — FDA 510(k) Clearance | Predicase

K-number	DEN070006
Device name	BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
Applicant	Inverness Medical Professional Diagnostics-Binax
Product code	OAX
Device class	Class II
Decision date	Jun 13, 2007
Decision	Not Substantially Equivalent
Regulation	866.3402

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View the full FDA submission: accessdata.fda.gov

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