Sofia Influenza A+B FIA on Sofia 2
K-Number: K162438 · 2017-04-14
ApplicantQuidel Corporation
Decision Date2017-04-14
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia Influenza A+B FIA on Sofia 2 is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-04-14 under approval number K162438. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofia Influenza A+B FIA on Sofia 2?
Sofia Influenza A+B FIA on Sofia 2 is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Quidel Corporation. The 510(k) number is K162438.
When was Sofia Influenza A+B FIA on Sofia 2 approved by the FDA?
Sofia Influenza A+B FIA on Sofia 2 received FDA 510(k) clearance on 2017-04-14, under approval number K162438.
What company makes Sofia Influenza A+B FIA on Sofia 2?
Sofia Influenza A+B FIA on Sofia 2 is manufactured by Quidel Corporation.
What is the FDA product code for Sofia Influenza A+B FIA on Sofia 2?
The FDA product code for Sofia Influenza A+B FIA on Sofia 2 is PSZ.
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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.