Sofia RSV FIA on Sofia 2 analyzer
K-Number: K162911 · 2017-02-22
ApplicantQuidel Corporation
Decision Date2017-02-22
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia RSV FIA on Sofia 2 analyzer is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-02-22 under approval number K162911. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofia RSV FIA on Sofia 2 analyzer?
Sofia RSV FIA on Sofia 2 analyzer is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Quidel Corporation. The 510(k) number is K162911.
When was Sofia RSV FIA on Sofia 2 analyzer approved by the FDA?
Sofia RSV FIA on Sofia 2 analyzer received FDA 510(k) clearance on 2017-02-22, under approval number K162911.
What company makes Sofia RSV FIA on Sofia 2 analyzer?
Sofia RSV FIA on Sofia 2 analyzer is manufactured by Quidel Corporation.
What is the FDA product code for Sofia RSV FIA on Sofia 2 analyzer?
The FDA product code for Sofia RSV FIA on Sofia 2 analyzer is GQG.
Other Devices by Quidel Corporation
Related Devices (Code: GQG)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.