The following data is part of a premarket notification filed by Ventana Medical Sytems, Inc with the FDA for Confirm Anti-progestorone Receptor (1e2) Rabbit Monoclonal Primary Antibody.
| Device ID | K103818 |
| 510k Number | K103818 |
| Device Name: | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | VENTANA MEDICAL SYTEMS, INC 1910 E. INNOVATIONS PARK DRIVE Tucson, AZ 85755 |
| Contact | George De La Rosa |
| Correspondent | George De La Rosa VENTANA MEDICAL SYTEMS, INC 1910 E. INNOVATIONS PARK DRIVE Tucson, AZ 85755 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-29 |
| Decision Date | 2011-11-16 |
| Summary: | summary |