510(k) K081286 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
| Applicant | Dako North America, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | May 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081286
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.