K101514

Substantially Equivalent

BD DIRECTIGEN EZ RSV

Applicant: Becton, Dickinson & CO
Product code: GQG
Advisory panel: Microbiology
Date received: 2010-06-02
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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