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FDA 510(k), K201902, MammaPrint
FDA 510(k), K201902, MammaPrint
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$149.00 USD
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510(K) Number: K201902
Device Name: MammaPrint
Manufacturer: Marcelo Trevino
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: NYI
Classification Product Code: 07/08/2020
Date Received: 11/05/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: MammaPrint
Manufacturer: Marcelo Trevino
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: NYI
Classification Product Code: 07/08/2020
Date Received: 11/05/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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