# Dako North America, Inc.

- Location (FDA's records): Carpinteria, CA
- FDA decisions: 6 (2005–2016): 4 510(k) clearances and 2 original PMA approvals
- Product codes: MXZ (2), MYA (2), PLS (1), NKF (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dakocytomation California, Inc.: 3 (https://510kreport.com/company/dakocytomation-california)

## Firms that cite its devices most
- Dako Denmark A/S: 2 (https://510kreport.com/company/dako-denmark-a-s)
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)

## Its most-cited devices
- K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link) (2013), cited by 2
- K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi (2013), cited by 2
- K081286: Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634 (2009), cited by 1

## Recent decisions
- K160922: FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (May 3, 2016)
- P150027: PD-L1 IHC 28-8 pharmDx (Jan 23, 2016)
- K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link) (Dec 9, 2013)
- K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi (Feb 12, 2013)
- K081286: Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634 (May 8, 2009)
- P040011: C-Kit Pharmdx (Jun 27, 2005)

Source page: https://510kreport.com/company/dako-north-america