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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K171974
Device Name Solana RSV+hMPV Assay
Applicant
Quidel Corporation
2005 East State Street, Suite 100
athens,  OH  45701
Applicant Contact ronald h. lollar
Correspondent
Quidel Corporation
2005 East State Street, Suite 100
athens,  OH  45701
Correspondent Contact ronald h. lollar
Regulation Number866.3980
Classification Product Code
OCC  
Date Received06/30/2017
Decision Date 10/16/2017
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
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