K934467 is an FDA 510(k) clearance for the BECKMAN CX AMMONIA/ALCOHOL CONTROL. This device is classified as a Alcohol Control Materials (Class I - General Controls, product code DKC).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on October 27, 1993, 47 days after receiving the submission on September 10, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K934467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1993 |
| Decision Date | October 27, 1993 |
| Days to Decision | 47 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 |