Sofia Strep A+ FIA, Sofia 2 Analyzer
K-Number: K171976 · 2017-12-21
ApplicantQuidel Corporation
Decision Date2017-12-21
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia Strep A+ FIA, Sofia 2 Analyzer is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-12-21 under approval number K171976. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofia Strep A+ FIA, Sofia 2 Analyzer?
Sofia Strep A+ FIA, Sofia 2 Analyzer is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Quidel Corporation. The 510(k) number is K171976.
When was Sofia Strep A+ FIA, Sofia 2 Analyzer approved by the FDA?
Sofia Strep A+ FIA, Sofia 2 Analyzer received FDA 510(k) clearance on 2017-12-21, under approval number K171976.
What company makes Sofia Strep A+ FIA, Sofia 2 Analyzer?
Sofia Strep A+ FIA, Sofia 2 Analyzer is manufactured by Quidel Corporation.
What is the FDA product code for Sofia Strep A+ FIA, Sofia 2 Analyzer?
The FDA product code for Sofia Strep A+ FIA, Sofia 2 Analyzer is GTY.
Other Devices by Quidel Corporation
Related Devices (Code: GTY)
Official Source
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