The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Confirm Anti-estrogen Receptor (sp1) Rabbit Monoclonal Primary Antibody.
| Device ID | K110215 |
| 510k Number | K110215 |
| Device Name: | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson, AZ 85755 |
| Contact | Roxane Bonner |
| Correspondent | Roxane Bonner VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson, AZ 85755 |
| Product Code | MYA |
| 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 | 2012-12-17 |
| Summary: | summary |