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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
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