Panels › Microbiology › Product code OWF · Class 1
Immunohistochemical Assay, Helicobacter Pylori
Regulation 866.3110
0510(k)s in 12 months (1 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 1 | 1 |
| Cell Marque Corporation | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2011 | K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc. | OWF |
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