K110215 is an FDA 510(k) clearance for the CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY. This device is classified as a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II - Special Controls, product code MYA).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on December 17, 2012, 719 days after receiving the submission on December 29, 2010.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860.
| 510(k) Number | K110215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2010 |
| Decision Date | December 17, 2012 |
| Days to Decision | 719 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |