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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
510(k) Number K130010
Device Name PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
Applicant
NANOSTRING TECHNOLOGIES
530 Fairview Ave N Ste 2000
Seattle,  WA  98109
Applicant Contact SYLVA KRIZAN, PHD
Correspondent
Veracyte, Inc.
6000 Shoreline Court, Suite 300
South San Fransisco,  CA  94080
Correspondent Contact Bonnie H Anderson
Regulation Number866.6040
Classification Product Code
NYI  
Subsequent Product Code
NSU  
Date Received01/03/2013
Decision Date 09/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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