BD DIRECTIGEN EZ FLU A+B TEST— 510(k) K063689

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K063689 for BD DIRECTIGEN EZ FLU A+B TEST, Substantially Equivalent on 2007-03-07. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code PSZ
Advisory panel: Microbiology
Date received: 2006-12-12
Decision date: 2007-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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