K932067 is an FDA 510(k) clearance for the ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III. This device is classified as a Alcohol Control Materials (Class I - General Controls, product code DKC).
Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 16, 1993, 48 days after receiving the submission on April 29, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K932067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1993 |
| Decision Date | June 16, 1993 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKC — Alcohol Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |