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 |
| 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 | K101234 |
| Jun 1, 2017 | Cell Marque Corporation H. pylori (polyclonal}
1.0 mL Catalog number 215A-76;
Hematology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
OWF | None listed |
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