K121350 is an FDA 510(k) clearance for the VIRTUSO SYSTEM FOR IHC (DO-7)..
Submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 1, 2012, 28 days after receiving the submission on May 4, 2012.
This device falls under the Pathology FDA review panel.
| 510(k) Number | K121350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2012 |
| Decision Date | June 01, 2012 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NOT |
| Device Class | — |