# Agendia BV

- Location (FDA's records): Amsterdam, NL
- FDA decisions: 8 (2007–2022): 7 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Agendia BV (3); Agendia (3); Agendia, Inc. (2)
- Product codes: NYI (8)
- Predicates its devices cite: 7 (7 its own); citations of its devices by later devices: 11 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Nanostring Technologies, Inc.: 2 (https://510kreport.com/company/nanostring-technologies)
- Iris Molecular Diagnostics: 1 (https://510kreport.com/company/iris-molecular-diagnostics)
- Abbott Molecular, Inc.: 1 (https://510kreport.com/company/abbott-molecular)

## Its most-cited devices
- DEN070009: Mammaprint (2007), cited by 4
- K081092: Modification to Mammaprint (2009), cited by 2
- K080252: Modification to Mammaprint (2008), cited by 1
- K201902: MammaPrint (2020), cited by 1
- K141142: Mammaprint Ffpe (2015), cited by 1
- K070675: Mammaprint (2007), cited by 1

## Recent decisions
- K210973: MammaPrint FFPE NGS Kit (Sep 8, 2022)
- K201902: MammaPrint (Nov 5, 2020)
- K141142: Mammaprint Ffpe (Jan 23, 2015)
- K101454: Mammaprint (Jan 28, 2011)
- K081092: Modification to Mammaprint (Dec 11, 2009)
- K080252: Modification to Mammaprint (Jul 21, 2008)
- K070675: Mammaprint (Jun 22, 2007)
- DEN070009: Mammaprint (Feb 6, 2007)

Source page: https://510kreport.com/company/agendia