Roche Diagnostics Corp. · Class II · Cleared Apr 15, 1999
| K-number | K990409 |
| Device name | ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) |
| Applicant | Roche Diagnostics Corp. |
| Product code | DMY |
| Device class | Class II |
| Decision date | Apr 15, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 862.3640 |
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