K871174 is an FDA 510(k) clearance for the 4-9295 BARBITURATES TEST MIX. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on June 11, 1987, 79 days after receiving the submission on March 24, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K871174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1987 |
| Decision Date | June 11, 1987 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |