Colony Laboratories, Inc. · Class II · Cleared Aug 28, 1989
| K-number | K894519 |
| Device name | FPR CARBAMAZEPINE KIT |
| Applicant | Colony Laboratories, Inc. |
| Product code | KLT |
| Device class | Class II |
| Decision date | Aug 28, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 862.3645 |
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