FDA 510(k), K080252, MODIFICATION TO MAMMAPRINT
FDA 510(k), K080252, MODIFICATION TO MAMMAPRINT
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510(K) Number: K080252
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: 01/31/2008
Decision Date: 07/21/2008
Regulation Medical Specialty: Immunology
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: 01/31/2008
Decision Date: 07/21/2008
Regulation Medical Specialty: Immunology