MammaPrint
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Agendia Inc.
The following data is part of a premarket notification filed by Agendia Inc. with the FDA for Mammaprint.
Pre-market Notification Details
| Device ID | K201902 |
| 510k Number | K201902 |
| Device Name: | MammaPrint |
| Classification | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Applicant | Agendia Inc. 22 Morgan Irvine, CA 92618 |
| Contact | Marcelo Trevino |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street Suite 2320 Philadelphia, PA 19103 |
| Product Code | NYI |
| CFR Regulation Number | 866.6040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2020-11-05 |
Trademark Results [MammaPrint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMAPRINT 79051001 3627122 Live/Registered |
AGENDIA BV 2007-11-27 |
 MAMMAPRINT 76618129 3261568 Live/Registered |
AGENDIA BV 2004-10-27 |
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