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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 K062694
Device Name MAMMAPRINT
Original Applicant
AGENDIA BV
louwesweg 6
amsterdam,  NL 1066 ec
Original Contact guildo brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received09/11/2006
Decision Date 02/06/2007
Decision de novo petitions granted (AN)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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