BINAXNOW INFLUENZA A & B TEST— 510(k) K053126

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K053126 for BINAXNOW INFLUENZA A & B TEST, Substantially Equivalent on 2005-11-30. Applicant: Binax, Inc..

Clearance details

Applicant: Binax, Inc.
Product code: Code PSZ
Advisory panel: Microbiology
Date received: 2005-11-07
Decision date: 2005-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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