K111543 is an FDA 510(k) clearance for the VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)..
Submitted by Ventana Medical Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 12, 2011, 132 days after receiving the submission on June 2, 2011.
This device falls under the Pathology FDA review panel.
| 510(k) Number | K111543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2011 |
| Decision Date | October 12, 2011 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NOT |
| Device Class | — |