# Diagenode

- Location (FDA's records): Seraing, BE
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: NJR (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cepheid: 1 (https://510kreport.com/company/cepheid)

## Recent decisions
- K181156: Panther Fusion GBS Assay (Jul 27, 2018)

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