QuickVue Influenza A+B
K-Number: K180288 · 2018-02-13
ApplicantQuidel Corporation
Decision Date2018-02-13
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
QuickVue Influenza A+B is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2018-02-13 under approval number K180288. 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 QuickVue Influenza A+B?
QuickVue Influenza A+B is a medical device that received FDA 510(k) clearance on 2018-02-13. It is manufactured by Quidel Corporation. The 510(k) number is K180288.
When was QuickVue Influenza A+B approved by the FDA?
QuickVue Influenza A+B received FDA 510(k) clearance on 2018-02-13, under approval number K180288.
What company makes QuickVue Influenza A+B?
QuickVue Influenza A+B is manufactured by Quidel Corporation.
What is the FDA product code for QuickVue Influenza A+B?
The FDA product code for QuickVue Influenza A+B is PSZ.
Other Devices by Quidel Corporation
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K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.
K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation
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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.