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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 K070675
Device Name MAMMAPRINT
Applicant
AGENDIA BV
louwesweg 6
amsterdam, 
Contact guido brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received03/12/2007
Decision Date 06/22/2007
Decision substantially equivalent - CLIA submission (CS)
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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