K083744

Substantially Equivalent

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

Applicant: Binax, Inc.
Product code: MJZ
Advisory panel: Clinical Chemistry
Date received: 2008-12-16
Decision date: 2009-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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