K140465 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER. This device is classified as a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II - Special Controls, product code NQN).
Submitted by Ventana Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 20, 2014, 24 days after receiving the submission on February 24, 2014.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860. Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention..
| 510(k) Number | K140465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2014 |
| Decision Date | March 20, 2014 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |
| Definition | Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention. |