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FDA 510(k), K180288, QuickVue Influenza A+B
FDA 510(k), K180288, QuickVue Influenza A+B
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510(K) Number: K180288
Device Name: QuickVue Influenza A+B
Manufacturer: Quidel Corporation
Device Classification Name: devices detecting influenza a, b, and c virus antigens
Regulation Number: 866.3328
Classification Product Code: PSZ
Date Received: 02/01/2018
Decision Date: 02/13/2018
Regulation Medical Specialty: Microbiology
Device Name: QuickVue Influenza A+B
Manufacturer: Quidel Corporation
Device Classification Name: devices detecting influenza a, b, and c virus antigens
Regulation Number: 866.3328
Classification Product Code: PSZ
Date Received: 02/01/2018
Decision Date: 02/13/2018
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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