K121033 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)..
Submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 6, 2013, 519 days after receiving the submission on April 5, 2012.
This device falls under the Pathology FDA review panel.
| 510(k) Number | K121033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2012 |
| Decision Date | September 06, 2013 |
| Days to Decision | 519 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NOT |
| Device Class | — |