Dako North America, Inc. · Class II · Cleared May 3, 2016
| K-number | K160922 |
| Device name | 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) |
| Applicant | Dako North America, Inc. |
| Product code | MXZ |
| Device class | Class II |
| Decision date | May 3, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 864.1860 |
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