K833514 is an FDA 510(k) clearance for the TOXI CHEM SERUM ALCOHOL CONTROL. This device is classified as a Alcohol Control Materials (Class I - General Controls, product code DKC).
Submitted by Fisher Diagnostics (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983, 58 days after receiving the submission on October 11, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K833514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1983 |
| Decision Date | December 08, 1983 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKC — Alcohol Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |