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FDA 510(k), K210973, MammaPrint FFPE NGS Kit
FDA 510(k), K210973, MammaPrint FFPE NGS Kit
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510(K) Number: K210973
Device Name: MammaPrint FFPE NGS Kit
Manufacturer: Marcelo Trevino
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: NYI
Classification Product Code: KXA
Date Received: 03/31/2021
Decision Date: 09/08/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: MammaPrint FFPE NGS Kit
Manufacturer: Marcelo Trevino
Device Classification Name: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation Number: NYI
Classification Product Code: KXA
Date Received: 03/31/2021
Decision Date: 09/08/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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