The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Er (sp1) With Benchmark Ultra Stainer.
| Device ID | K140465 |
| 510k Number | K140465 |
| Device Name: | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 203 RAVENDALE DR Mountain View, CA 94043 |
| Contact | Mort Minaee |
| Correspondent | Mort Minaee VENTANA MEDICAL SYSTEMS, INC. 203 RAVENDALE DR Mountain View, CA 94043 |
| Product Code | NQN |
| Subsequent Product Code | NOT |
| Subsequent Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-03-20 |
| Summary: | summary |