Cleared Traditional

BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

K132456 · Becton, Dickinson and Company · Microbiology
Nov 2013
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K132456 is an FDA 510(k) clearance for the BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Becton, Dickinson and Company (San Diego, US). The FDA issued a Cleared decision on November 7, 2013, 93 days after receiving the submission on August 6, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K132456 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2013
Decision Date November 07, 2013
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3480

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