The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Pr (1e2) Benchmark Ultra Stainer.
Device ID | K122143 |
510k Number | K122143 |
Device Name: | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER |
Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
Contact | Erika B Ammirati |
Correspondent | Erika B Ammirati VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
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 | 2012-07-19 |
Decision Date | 2013-09-19 |
Summary: | summary |