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510(k) K153012

Sofia Influenza A+B FIA by Quidel Corporation — Product Code PSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2016
Date Received
October 14, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices Detecting Influenza A, B, And C Virus Antigens
Device Class
Class II
Regulation Number
866.3328
Review Panel
MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

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