FDA 510(k), K081092, MODIFICATION TO MAMMAPRINT
FDA 510(k), K081092, MODIFICATION TO MAMMAPRINT
Device Name: MODIFICATION TO MAMMAPRINT
Manufacturer:
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: 866.6040
Classification Product Code: NYI
Date Received: 04/17/2008
Decision Date: 12/11/2009
Regulation Medical Specialty: Immunology
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