510(k) K183100 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
| Applicant | Leica Biosystems Newcastle, Limited, Newcastle Upon Tyne, GB |
| Decision | Substantially Equivalent, Dec 7, 2018 |
| Received | Nov 7, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183100
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.