The following data is part of a premarket notification filed by Nanostring Technologies Inc. with the FDA for Prosigna Breast Cancer Prognostic Gene Signature Assay.
| Device ID | K141771 |
| 510k Number | K141771 |
| Device Name: | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY |
| Classification | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Applicant | NANOSTRING TECHNOLOGIES INC. 530 FAIRVIEW AVE N, SUITE 2000 Seattle, WA 98109 |
| Contact | Sylva Krizan |
| Correspondent | Sylva Krizan NANOSTRING TECHNOLOGIES INC. 530 FAIRVIEW AVE N, SUITE 2000 Seattle, WA 98109 |
| Product Code | NYI |
| CFR Regulation Number | 866.6040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-01 |
| Decision Date | 2014-11-07 |
| Summary: | summary |