510(k) K122556 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
| Applicant | Leica Biosystems Newcastle, Ltd., Richmond IL, US |
| Decision | Substantially Equivalent, May 19, 2014 |
| Received | Aug 22, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122556
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.