Cleared Traditional

BD DIRECTIGEN EZ RSV

K101514 · Becton, Dickinson & CO · Microbiology

Jul 2010

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K101514 is an FDA 510(k) clearance for the BD DIRECTIGEN EZ RSV, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Becton, Dickinson & CO (La Jolla, US). The FDA issued a Cleared decision on July 9, 2010, 37 days after receiving the submission on June 2, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K101514 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2010
Decision Date	July 09, 2010
Days to Decision	37 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