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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K142346
Device Name Urine/CSF Albumin, Urine/CSF Albumin Calibrator
Applicant
Beckman Coulter Ireland, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Applicant Contact Anne-Marie Shine
Correspondent
Beckman Coulter Ireland, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Correspondent Contact Anne-Marie Shine
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Code
JIT  
Date Received08/22/2014
Decision Date 10/15/2014
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
Predetermined Change
Control Plan Authorized		 No
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