Cleared Dual Track

Sofia Strep A+ FIA, Sofia 2 Analyzer

K171976 · Quidel Corporation · Microbiology
Dec 2017
Decision
174d
Days
Class 1
Risk

About This 510(k) Submission

K171976 is an FDA 510(k) clearance for the Sofia Strep A+ FIA, Sofia 2 Analyzer, 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 December 21, 2017, 174 days after receiving the submission on June 30, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K171976 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2017
Decision Date December 21, 2017
Days to Decision 174 days
Submission Type Dual Track
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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