Device Classification Name |
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
More FDA Info for this Device |
510(K) Number |
K141771 |
Device Name |
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
Applicant |
NANOSTRING TECHNOLOGIES INC.
530 FAIRVIEW AVE N,
SUITE 2000
SEATTLE, WA 98109 US
Other 510(k) Applications for this Company
|
Contact |
SYLVA KRIZAN
Other 510(k) Applications for this Contact |
Regulation Number |
866.6040
More FDA Info for this Regulation Number |
Classification Product Code |
NYI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/01/2014 |
Decision Date |
11/07/2014 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
PA - Pathology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|