510(k) K101234 ยท OWF Immunohistochemical Assay, Helicobacter Pylori
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
| Applicant | Ventana Medical Systems, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Aug 25, 2011 |
| Received | May 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
OWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.