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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 K092505
Device Name BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
Applicant
Beckman Coulter, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Applicant Contact CATRIONA NEILAN
Correspondent
Beckman Coulter, Inc.
Lismeehan
O' Callaghan'S, Mills
Co. Clare,  IE
Correspondent Contact CATRIONA NEILAN
Regulation Number866.5340
Classification Product Code
DBF  
Date Received08/14/2009
Decision Date 12/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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