K103610

Substantially Equivalent

CLEARVIEW EXACT II INFLUENZA A & B TEST

Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
Product code: PSZ
Advisory panel: Microbiology
Date received: 2010-12-09
Decision date: 2011-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

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