| K-number | K935346 |
| Device name | CEDIA(R) DAU OPIATE ASSAY |
| Applicant | Microgenics Corp. |
| Product code | DJG |
| Device class | Class II |
| Decision date | Jan 11, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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