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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
510(k) Number K162274
Device Name Solana Strep Complete Assay
Applicant
Quidel Corporation
2005 E. State St., Suite 100
Athens,  OH  45701
Applicant Contact Ronald H Lollar
Correspondent
Quidel Corporation
2005 E. State St., Suite 100
Athens,  OH  45701
Correspondent Contact Ronald H Lollar
Regulation Number866.2680
Classification Product Code
PGX  
Date Received08/12/2016
Decision Date 10/25/2016
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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