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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 K141775
Device Name SOFIA (R) STREP A+ FIA
Applicant
Quidel Corporation
12544 High Bluff (Administrative Office Location)
San Diego,  CA  92130
Applicant Contact JOHN D TAMERIUS
Correspondent
Quidel Corporation
12544 High Bluff (Administrative Office Location)
San Diego,  CA  92130
Correspondent Contact JOHN D TAMERIUS
Regulation Number866.3740
Classification Product Code
GTY  
Date Received07/01/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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