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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K170491
Device Name Solana C. difficile 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 Number866.3130
Classification Product Code
OZN  
Date Received02/17/2017
Decision Date 05/11/2017
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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