The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Pgr Primary Antibody (clone 1a6).
| Device ID | K990618 |
| 510k Number | K990618 |
| Device Name: | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Judith Frederick |
| Correspondent | Judith Frederick VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-25 |
| Decision Date | 1999-07-23 |
| Summary: | summary |