Data / Medical devices / Netherlands / Agendia NV
Agendia NV: FDA-registered device maker in Amsterdam Noord-Holland, Netherlands, 2 510(k) clearances
Agendia NV is registered with the FDA (registration 3017845262) in Amsterdam Noord-Holland, Netherlands. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017845262
- Address
- Radarweg 60, Amsterdam Noord-Holland, Netherlands, 1043 NT
- Owner or operator
- AGENDIA Inc. (9101719)
- Roles
- Specification developer
- First device listed
- November 27, 2018
- Registered through
- 2026
- Brand names listed
- Agendia Specimen Collection Kit, MammaPrint® FFPE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | NYI | 2 | Specification developer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 5, 2020 | K201902 | MammaPrint | NYI | Substantially Equivalent | Agendia, Inc. | accessdata.fda.gov |
| January 23, 2015 | K141142 | MAMMAPRINT FFPE | NYI | Substantially Equivalent | Agendia | accessdata.fda.gov |
Compare with other makers
- All makers of Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated November 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.