K912827 is an FDA 510(k) clearance for the SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3. This device is classified as a Alcohol Control Materials (Class I - General Controls, product code DKC).
Submitted by Cala Diagnostics (Los Osos, US). The FDA issued a Cleared decision on August 12, 1991, 47 days after receiving the submission on June 26, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K912827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1991 |
| Decision Date | August 12, 1991 |
| Days to Decision | 47 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 |