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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigens, cf (including cf control), influenza virus a, b, c
510(k) Number K131606
Device Name SOFIA INFLUENZA A+B FIA
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Applicant Contact JOHN D TAMERIUS, PH.D.
Correspondent
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Correspondent Contact JOHN D TAMERIUS, PH.D.
Regulation Number866.3330
Classification Product Code
GNX  
Date Received06/03/2013
Decision Date 07/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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