The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Toxi Chem Serum Alcohol Control.
| Device ID | K833514 |
| 510k Number | K833514 |
| Device Name: | TOXI CHEM SERUM ALCOHOL CONTROL |
| Classification | Alcohol Control Materials |
| Applicant | FISHER DIAGNOSTICS 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 | 1983-10-11 |
| Decision Date | 1983-12-08 |