K122556 is an FDA 510(k) clearance for the VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11). This device is classified as a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II - Special Controls, product code MYA).
Submitted by Leica Biosystems Newcastle, Ltd. (Richmond, US). The FDA issued a Cleared decision on May 19, 2014, 635 days after receiving the submission on August 22, 2012.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860.
| 510(k) Number | K122556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2012 |
| Decision Date | May 19, 2014 |
| Days to Decision | 635 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 |