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FDA 510(k) Application Details - DEN070009
Device Classification Name
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
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510(K) Number
DEN070009
Device Name
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Applicant
AGENDIA BV
LOUWESWEG 6
AMSTERDAM 1066 EC NL
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GUILDO BRINK
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Regulation Number
866.6040
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Classification Product Code
NYI
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Date Received
01/30/2007
Decision Date
02/06/2007
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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