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510(k) K162911

Sofia RSV FIA on Sofia 2 analyzer by Quidel Corporation — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2017
Date Received
October 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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