The following data is part of a premarket notification filed by Ventana, Inc. with the FDA for Ventana Er Primary Antibody (clone 6f11).
| Device ID | K984567 |
| 510k Number | K984567 |
| Device Name: | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | VENTANA, INC. 3865 NORTH BUSINESS CENTER DRIVE Tucson, AZ 85705 |
| Contact | Judith Frederick |
| Correspondent | Judith Frederick VENTANA, INC. 3865 NORTH BUSINESS CENTER DRIVE Tucson, AZ 85705 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-08-12 |
| Summary: | summary |