BD Veritor System Flu A+B Assay— 510(k) K133138

Name: FDA 510(k) clearance K133138
Creator: U.S. Food and Drug Administration
Published: 2013-11-13

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K133138 for BD Veritor System Flu A+B Assay, Substantially Equivalent on 2013-11-13. 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: 2013-10-17
Decision date: 2013-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSZ

view all

K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA2026-09-04
K252283 — Nano-Check Influenza A+B Test2026-01-15
K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System2025-04-18
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit2023-12-05

More clearances from Becton, Dickinson & CO

view all

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