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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antigen, cf (including cf controls), respiratory syncytial virus
510(k) Number K162911
Device Name Sofia RSV FIA on Sofia 2 analyzer
Applicant
Quidel Corporation
12544 High Bluff Drive, Suite 200
San Diego,,  CA  92130
Applicant Contact Edward C. Brehm
Correspondent
Quidel Corporation
12544 High Bluff Drive, Suite 200
San Diego,,  CA  92130
Correspondent Contact Edward C. Brehm
Regulation Number866.3480
Classification Product Code
GQG  
Subsequent Product Code
KHO  
Date Received10/17/2016
Decision Date 02/22/2017
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
Recalls CDRH Recalls
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