510(k) K110215 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
| Applicant | Ventana Medical Systems, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Dec 17, 2012 |
| Received | Dec 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.