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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c-reactive protein, antigen, antiserum, and control
510(k) Number K192118
Device Name CRP Vario
Applicant
Sentinel CH, Spa
Via Robert Koch, 2
Milano,  IT 20152
Applicant Contact Patricia Dupe
Correspondent
Sentinel CH, Spa
Via Robert Koch, 2
Milano,  IT 20152
Correspondent Contact Patricia Dupe
Regulation Number866.5270
Classification Product Code
DCK  
Date Received08/06/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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