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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
Original Applicant
AGENDIA BV
louwesweg 6
amsterdam,  NL 1066 ec
Original 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
Recalls CDRH Recalls
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