PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY— 510(k) K130010

Substantially Equivalent

Nanostring Technologies

FDA 510(k) clearance K130010 for PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY, Substantially Equivalent on 2013-09-06. Applicant: Nanostring Technologies.

Clearance details

Applicant: Nanostring Technologies
Product code: Code NYI
Advisory panel: Immunology
Date received: 2013-01-03
Decision date: 2013-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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