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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reagents for detection of norovirus nucleic acid
510(k) Number K171511
Device Name RIDA GENE Norovirus GI/GII
R-Biopharm AG
An der neuen Bergstrabe 17
Darmstadt,  DE 64297
Applicant Contact Andreas Simons
R-Biopharm Inc
870 Vossbrink Drive
Washington,  MO  63090
Correspondent Contact Patricia Meinhardt
Regulation Number866.3990
Classification Product Code
Subsequent Product Code
Date Received05/24/2017
Decision Date 08/21/2017
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