510(k) K160922 ยท MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
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., Carpinteria CA, US |
| Decision | Substantially Equivalent, May 3, 2016 |
| Received | Apr 4, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160922
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.