510(k) K103818 ยท MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
| Applicant | Ventana Medical Sytems, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Nov 16, 2011 |
| Received | Dec 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.