K990618 is an FDA 510(k) clearance for the VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6). This device is classified as a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II - Special Controls, product code MXZ).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on July 23, 1999, 148 days after receiving the submission on February 25, 1999.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860.
| 510(k) Number | K990618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1999 |
| Decision Date | July 23, 1999 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |