CLEARVIEW EXACT II INFLUENZA A & B TEST— 510(k) K103610

Substantially Equivalent

Alere Scarborough, Inc D/B/A Binax, Inc.

FDA 510(k) clearance K103610 for CLEARVIEW EXACT II INFLUENZA A & B TEST, Substantially Equivalent on 2011-01-06. Applicant: Alere Scarborough, Inc D/B/A Binax, Inc..

Clearance details

Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.