Genzyme Diagnostics · Class II · Cleared Feb 25, 1997
| K-number | K963425 |
| Device name | GENZYME DIAGNOSTICS CONTRAST MONO |
| Applicant | Genzyme Diagnostics |
| Product code | KTN |
| Device class | Class II |
| Decision date | Feb 25, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.5640 |
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