FDA 510(k), K141142, MAMMAPRINT FFPE
FDA 510(k), K141142, MAMMAPRINT FFPE
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510(K) Number: K141142
Device Name: MAMMAPRINT FFPE
Manufacturer:
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: 866.6040
Classification Product Code: NYI
Date Received: 05/02/2014
Decision Date: 01/23/2015
Regulation Medical Specialty: Immunology
Device Name: MAMMAPRINT FFPE
Manufacturer:
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: 866.6040
Classification Product Code: NYI
Date Received: 05/02/2014
Decision Date: 01/23/2015
Regulation Medical Specialty: Immunology