510(k) K170028 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
| Applicant | Dako Denmark A/S, Golstrup, DK |
| Decision | Substantially Equivalent, Dec 21, 2017 |
| Received | Jan 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170028
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.