Dako Denmark A/S
FDA 510(k) & PMA Approved Devices — 3 products
Total Devices3
Categories3
Latest FDA decision2017-12-21
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | MYA | 2017-12-21 | View |
| 510(k) | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | MXZ | 2017-12-21 | View |
| PMA | P100024 | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer | NYQ | 2017-04-12 | View |
No matching devices.