BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit— 510(k) K160161

Name: FDA 510(k) clearance K160161
Creator: U.S. Food and Drug Administration
Published: 2016-02-24

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K160161 for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit, Substantially Equivalent on 2016-02-24. 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: 2016-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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