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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 K101454
Device Name MAMMAPRINT
Applicant
AGENDIA
science park 406
amsterdam, 
Contact guido brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received05/25/2010
Decision Date 01/28/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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