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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(k) Number K173250
Device Name Solana GBS 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 Number866.3740
Classification Product Code
NJR  
Date Received10/10/2017
Decision Date 12/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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