The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Anti-helicobacter Pylori (sp48) Rabbit Monoclonal Primary Antibody.
| Device ID | K101234 |
| 510k Number | K101234 |
| Device Name: | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Classification | Immunohistochemical Assay, Helicobacter Pylori |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson, AZ 85755 |
| Contact | Judy Howe |
| Correspondent | Judy Howe VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson, AZ 85755 |
| Product Code | OWF |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2011-08-25 |
| Summary: | summary |