The following data is part of a De Novo classification by Vysis with the FDA for Vysis Autovysion System.
| DeNovo ID | DEN040010 |
| Device Name: | VYSIS AUTOVYSION SYSTEM |
| Classification | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays |
| Applicant | VYSIS 3100 Woodcreek Dr. Downers Grove, IL 60515 |
| Contact | Lynda Hague |
| Product Code | NTH |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K041875 |
| Review Advisory Board | Pathology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2004-10-13 |
| Decision Date | 2004-12-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999001848 | DEN040010 | 000 |
| 00884999001824 | DEN040010 | 000 |