K-number	K130010
Device name	PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
Applicant	Nanostring Technologies
Product code	NYI
Device class	Class II
Decision date	Sep 6, 2013
Decision	Substantially Equivalent
Regulation	866.6040

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Source

View the full FDA submission: accessdata.fda.gov

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PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

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