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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K083602
Device Name KAPPA LIGHT CHAINS
Applicant
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Applicant Contact YANGTSE PORTELLES
Correspondent
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Correspondent Contact YANGTSE PORTELLES
Regulation Number866.5550
Classification Product Code
DFH  
Date Received12/05/2008
Decision Date 09/03/2009
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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