Cleared Traditional

SOFIA STREP A FIA

K123793 · Quidel Corporation · Microbiology
Jun 2013
Decision
189d
Days
Class 1
Risk

About This 510(k) Submission

K123793 is an FDA 510(k) clearance for the SOFIA STREP A FIA, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on June 17, 2013, 189 days after receiving the submission on December 10, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K123793 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2012
Decision Date June 17, 2013
Days to Decision 189 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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