510(k) K984567 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
| Applicant | Ventana, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Aug 12, 1999 |
| Received | Dec 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2011 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an Terminated |
MYA | None listed |
| Jul 1, 2011 | Ventana Medical Systems Inc iView DAB Detection Kit, Part number: 760-091
(05266157001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect bioti Terminated |
MYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.