Roche Diagnostic Systems, Inc. · Class II · Cleared Feb 1, 1985
| K-number | K843825 |
| Device name | COBAS REAGENTS PHENOBARBITAL & PHENOBAR |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | LGQ |
| Device class | Class II |
| Decision date | Feb 1, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 862.3660 |
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