Sofia Influenza A+B FIA
K-Number: K153012 · 2016-01-12
ApplicantQuidel Corporation
Decision Date2016-01-12
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia Influenza A+B FIA is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2016-01-12 under approval number K153012. 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?
Sofia Influenza A+B FIA is a medical device that received FDA 510(k) clearance on 2016-01-12. It is manufactured by Quidel Corporation. The 510(k) number is K153012.
When was Sofia Influenza A+B FIA approved by the FDA?
Sofia Influenza A+B FIA received FDA 510(k) clearance on 2016-01-12, under approval number K153012.
What company makes Sofia Influenza A+B FIA?
Sofia Influenza A+B FIA is manufactured by Quidel Corporation.
What is the FDA product code for Sofia Influenza A+B FIA?
The FDA product code for Sofia Influenza A+B FIA is PSZ.
Other Devices by Quidel Corporation
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K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation
K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.
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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.