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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K123793
Device Name SOFIA STREP A FIA
Applicant
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact JOHN D TAMERIUS, PH.D.
Correspondent
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact JOHN D TAMERIUS, PH.D.
Regulation Number866.3740
Classification Product Code
GTY  
Subsequent Product Code
KHO  
Date Received12/10/2012
Decision Date 06/17/2013
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
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