| K-number | K802618 |
| Device name | EMIT-STM ETHYL ALCOHOL URINE CONTROLS |
| Applicant | Syva Co. |
| Product code | DKC |
| Device class | Class I |
| Decision date | Oct 31, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.3280 |
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