PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY— 510(k) K141771

Name: FDA 510(k) clearance K141771
Creator: U.S. Food and Drug Administration
Published: 2014-11-07

Substantially Equivalent

Nanostring Technologies, Inc.

FDA 510(k) clearance K141771 for PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY, Substantially Equivalent on 2014-11-07. Applicant: Nanostring Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Nanostring Technologies, Inc.
Product code: Code NYI
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2014-07-01
Decision date: 2014-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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