# Dako Denmark A/S

- Location (FDA's records): Glostrup
- FDA decisions: 4 (2008–2017): 2 510(k) clearances and 2 original PMA approvals
- Product codes: NYQ (1), MYA (1), MXZ (1), NXG (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dako North America, Inc.: 2 (https://510kreport.com/company/dako-north-america)

## Recent decisions
- K170028: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (Dec 21, 2017)
- K170005: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (Dec 21, 2017)
- P100024: HER2 Cish Pharmdx Kit (Nov 30, 2011)
- P050045: Dako TOP2A Fish Pharmdx Kit (Jan 11, 2008)

Source page: https://510kreport.com/company/dako-denmark-a-s