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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 K191993
Device Name Yumizen C1200 CRP
Applicant
Horiba ABX SAS
Parc Euromedecine, Rue du Caducee BP7290
Montpellier Cedex 4,  FR 341184
Applicant Contact Caroline Ferrer
Correspondent
Horiba ABX SAS
Parc Euromedecine, Rue du Caducee BP7290
Montpellier Cedex 4,  FR 34184
Correspondent Contact Caroline Ferrer
Regulation Number866.5270
Classification Product Code
DCK  
Date Received07/25/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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