BD Veritor System for Rapid Detection of Flu A + B Labratory Kit— 510(k) K160164

Name: FDA 510(k) clearance K160164
Creator: U.S. Food and Drug Administration
Published: 2016-02-25

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K160164 for BD Veritor System for Rapid Detection of Flu A + B Labratory Kit, Substantially Equivalent on 2016-02-25. Applicant: Becton, Dickinson & CO. Device class: 2.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2016-01-27
Decision date: 2016-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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