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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
510(k) Number K141142
FOIA Releasable 510(k) K141142
Device Name MAMMAPRINT FFPE
Applicant
AGENDIA
SCIENCE PARK 406
AMSTERDAM,  NL 1098XH
Applicant Contact Guido Brink
Correspondent
AGENDIA
SCIENCE PARK 406
AMSTERDAM,  NL 1098XH
Correspondent Contact Guido Brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received05/02/2014
Decision Date 01/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
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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