Cleared Traditional

SOFIA(R) RSV FIA

K130398 · Quidel Corp. · Microbiology

Aug 2013

Decision

175d

Days

Class 1

Risk

About This 510(k) Submission

K130398 is an FDA 510(k) clearance for the SOFIA(R) RSV FIA, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 13, 2013, 175 days after receiving the submission on February 19, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K130398 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2013
Decision Date	August 13, 2013
Days to Decision	175 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