Agendia BV: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Agendia BV” (first 2007, latest 2008), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 137 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | 3 | 2 |
Review panels
- Pathology (3)
Most recent Agendia BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080252 | MODIFICATION TO MAMMAPRINT | NYI | 2008-07-21 | 172 |
| K070675 | MAMMAPRINT | NYI | 2007-06-22 | 102 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN070009 | De Novo | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | 2007-02-06 |
Recalls
openFDA lists no recalls under a recalling firm named Agendia BV.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Agendia (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Agendia BV?
FDA lists 2 510(k) clearances under the applicant name “Agendia BV” (first 2007, latest 2008), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Agendia BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agendia BV is 137 days.
Which FDA product codes appear under Agendia BV?
The most frequent FDA product codes under this applicant name are NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer, 3).
Next steps
- See all 2 Agendia BV clearances with predicates and recalls
- Run predicate analysis for product code NYI, Agendia BV's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.