510(k) K013148 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
| Applicant | Biogenex Laboratories, San Ramon CA, US |
| Decision | Substantially Equivalent, Feb 28, 2002 |
| Received | Sep 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013148
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.