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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K190851
Device Name HYDRASHIFT 2/4 daratumumab
Applicant
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Applicant Contact Karen Anderson
Correspondent
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Correspondent Contact Karen Anderson
Regulation Number866.5510
Classification Product Code
CFF  
Date Received04/02/2019
Decision Date 05/02/2019
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
Predetermined Change
Control Plan Authorized		 No
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