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U.S. Department of Health and Human Services

Device Classification under Section 513(f)(2)(de novo)

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Device Classification Name classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
De Novo Number DEN070009
510(K) Number K062694
Device Name MAMMAPRINT
Requester
AGENDIA BV
louwesweg 6
amsterdam,  NL 1066 ec
Contact guildo brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received01/30/2007
Decision Date 02/06/2007
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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