K935819 is an FDA 510(k) clearance for the QUALITY CONTROL MATERIAL (ASSAYED). This device is classified as a Alcohol Control Materials (Class I - General Controls, product code DKC).
Submitted by Columbia Diagnostics, Inc. (Springfield, US). The FDA issued a Cleared decision on March 22, 1994, 109 days after receiving the submission on December 3, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K935819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1993 |
| Decision Date | March 22, 1994 |
| Days to Decision | 109 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 |