Roche Diagnostic Systems, Inc. · Class II · Cleared Oct 9, 1997
| K-number | K973075 |
| Device name | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | DKZ |
| Device class | Class II |
| Decision date | Oct 9, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
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