The following data is part of a premarket notification filed by Agendia Inc. with the FDA for Mammaprint Ffpe Ngs Kit.
| Device ID | K210973 |
| 510k Number | K210973 |
| Device Name: | MammaPrint FFPE NGS Kit |
| Classification | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Applicant | Agendia Inc. 22 Morgan Irvine, CA 92618 |
| Contact | Marcelo Trevino |
| Correspondent | Marcelo Trevino Agendia Inc. 22 Morgan Irvine, CA 92618 |
| Product Code | NYI |
| CFR Regulation Number | 866.6040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2022-09-08 |