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FDA 510(k), K162438, Sofia Influenza A+B FIA on Sofia 2
FDA 510(k), K162438, Sofia Influenza A+B FIA on Sofia 2
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510(K) Number: K162438
Device Name: Sofia Influenza A+B FIA on Sofia 2
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: 08/31/2016
Decision Date: 04/14/2017
Regulation Medical Specialty: Microbiology
Device Name: Sofia Influenza A+B FIA on Sofia 2
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: 08/31/2016
Decision Date: 04/14/2017
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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