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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indirect Copper Assay, Ceruloplasmin
510(k) Number K051456
Device Name SENTINEL CERULOPLASMIN
Applicant
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Applicant Contact DAVIDE SPADA
Correspondent
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Correspondent Contact DAVIDE SPADA
Regulation Number866.5210
Classification Product Code
JFR  
Date Received06/02/2005
Decision Date 10/21/2005
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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