BD Veritor System for SARS-CoV-2— 510(k) K261379

Name: FDA 510(k) clearance K261379
Creator: U.S. Food and Drug Administration
Published: 2026-10-27

Substantially Equivalent

BD Diagnostic Solutions / Becton, Dickinson & Company

FDA 510(k) clearance K261379 for BD Veritor System for SARS-CoV-2, Substantially Equivalent on 2026-10-27. Applicant: BD Diagnostic Solutions / Becton, Dickinson & Company. Device class: 2.

Clearance details

Applicant: BD Diagnostic Solutions / Becton, Dickinson & Company
Product code: Product code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2026-04-27
Decision date: 2026-10-27
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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