The following data is part of a premarket notification filed by Agendia with the FDA for Modification To Mammaprint.
| Device ID | K081092 |
| 510k Number | K081092 |
| Device Name: | MODIFICATION TO MAMMAPRINT |
| Classification | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Applicant | AGENDIA KRUISLAAN 406 Amsterdam, NL 1098sm |
| Contact | Guido Brink |
| Correspondent | Guido Brink AGENDIA KRUISLAAN 406 Amsterdam, NL 1098sm |
| Product Code | NYI |
| CFR Regulation Number | 866.6040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-17 |
| Decision Date | 2009-12-11 |
| Summary: | summary |