| K-number | DEN040010 |
| Device name | VYSIS AUTOVYSION SYSTEM |
| Applicant | Vysis |
| Product code | NTH |
| Device class | Class II |
| Decision date | Dec 13, 2004 |
| Decision | Not Substantially Equivalent |
| Regulation | 866.4700 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov