Cleared Special

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV

K133140 · Becton, Dickinson & CO · Microbiology

Nov 2013

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K133140 is an FDA 510(k) clearance for the BD VERITOR 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 & CO (San Diego, US). The FDA issued a Cleared decision on November 15, 2013, 29 days after receiving the submission on October 17, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K133140 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2013
Decision Date	November 15, 2013
Days to Decision	29 days
Submission Type	Special
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