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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ceruloplasmin, Antigen, Antiserum, Control
510(k) Number K161508
Device Name Ceruloplasmin
Applicant
Beckman Coulter Ireland, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Applicant Contact MARGUERITA SWEENEY
Correspondent
Beckman Coulter Ireland, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Correspondent Contact MARGUERITA SWEENEY
Regulation Number866.5210
Classification Product Code
DDB  
Date Received06/01/2016
Decision Date 01/09/2017
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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