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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K162438
Device Name Sofia Influenza A+B FIA on Sofia 2
Applicant
Quidel Corporation
12544 High Bluff Dr., Suite 200
San Diego,,  CA  92130
Applicant Contact Jennifer S. Rial
Correspondent
Quidel Corporation
12544 High Bluff Dr., Suite 200
San Diego,,  CA  92130
Correspondent Contact Jennifer S. Rial
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/31/2016
Decision Date 04/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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