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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 K171976
Device Name Sofia Strep A+ FIA, Sofia 2 Analyzer
Applicant
Quidel Corporation
12544 High Bluff Dr., Suite 200
San Diego,,  CA  92130
Applicant Contact Edward C. Brehm
Correspondent
Quidel Corporation
12544 High Bluff Dr., Suite 200
San Diego,,  CA  92130
Correspondent Contact Edward C. Brehm
Regulation Number866.3740
Classification Product Code
GTY  
Subsequent Product Code
KHO  
Date Received06/30/2017
Decision Date 12/21/2017
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
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