K933425 is an FDA 510(k) clearance for the AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812. 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 November 16, 1993, 126 days after receiving the submission on July 13, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K933425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1993 |
| Decision Date | November 16, 1993 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DKC — Alcohol Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |