Cleared Traditional

Sofia RSV FIA on Sofia 2 analyzer

K162911 · Quidel Corporation · Microbiology

Feb 2017

Decision

128d

Days

Class 1

Risk

About This 510(k) Submission

K162911 is an FDA 510(k) clearance for the Sofia RSV FIA on Sofia 2 analyzer, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on February 22, 2017, 128 days after receiving the submission on October 17, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K162911 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2016
Decision Date	February 22, 2017
Days to Decision	128 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