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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K191562
Device Name Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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 341184
Correspondent Contact Caroline Ferrer
Regulation Number866.5340
Classification Product Code
DBF  
Subsequent Product Codes
DDG   DHR  
Date Received06/13/2019
Decision Date 03/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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