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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 K080252
FOIA Releasable 510(k) K080252
Device Name MODIFICATION TO MAMMAPRINT
Applicant
AGENDIA BV
LOUWESWEG 6
AMSTERDAM,  NL 1066 EC
Applicant Contact Guido Brink
Correspondent
AGENDIA BV
LOUWESWEG 6
AMSTERDAM,  NL 1066 EC
Correspondent Contact Guido Brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received01/31/2008
Decision Date 07/21/2008
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
Recalls CDRH Recalls
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