The following data is part of a premarket notification filed by Nanostring Technologies with the FDA for Prosigna(tm) Breast Cancer Prognostic Gene Signature Assay.
| Device ID | K130010 |
| 510k Number | K130010 |
| Device Name: | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY |
| Classification | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Applicant | NANOSTRING TECHNOLOGIES 530 Fairview Ave N Ste 2000 Seattle, WA 98109 |
| Contact | Sylva Krizan, Phd |
| Correspondent | Sylva Krizan NANOSTRING TECHNOLOGIES 530 Fairview Ave N Ste 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 | 2013-01-03 |
| Decision Date | 2013-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859812006065 | K130010 | 000 |
| 00859812006058 | K130010 | 000 |
| 00859812006041 | K130010 | 000 |
| 00859812006034 | K130010 | 000 |
| 00859812006027 | K130010 | 000 |
| 00859812006010 | K130010 | 000 |
| 00859812006003 | K130010 | 000 |