The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit-stm Ethyl Alcohol Urine Controls.
| Device ID | K802618 |
| 510k Number | K802618 |
| Device Name: | EMIT-STM ETHYL ALCOHOL URINE CONTROLS |
| Classification | Alcohol Control Materials |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKC |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-20 |
| Decision Date | 1980-10-31 |