Cleared Traditional

BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV

K121633 · Becton, Dickinson and Company · Microbiology
Sep 2012
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K121633 is an FDA 510(k) clearance for the BD VERITOR(TM) SYSTEM FOR THE 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 September 18, 2012, 106 days after receiving the submission on June 4, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K121633 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2012
Decision Date September 18, 2012
Days to Decision 106 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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