Cleared Traditional

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP

K122718 · Becton, Dickinson and Company · Microbiology
Feb 2013
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K122718 is an FDA 510(k) clearance for the BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Becton, Dickinson and Company (San Diego, US). The FDA issued a Cleared decision on February 6, 2013, 154 days after receiving the submission on September 5, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K122718 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2012
Decision Date February 06, 2013
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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