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FDA 510(k), K130010, PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
FDA 510(k), K130010, PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
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510(K) Number: K130010
Device Name: PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
Manufacturer: NANOSTRING TECHNOLOGIES
Device Classification Name: classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Regulation Number: 866.6040
Classification Product Code: NYI
Date Received: 01/03/2013
Decision Date: 09/06/2013
Regulation Medical Specialty: Immunology
Device Name: PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
Manufacturer: NANOSTRING TECHNOLOGIES
Device Classification Name: classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Regulation Number: 866.6040
Classification Product Code: NYI
Date Received: 01/03/2013
Decision Date: 09/06/2013
Regulation Medical Specialty: Immunology
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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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