K092268 is an FDA 510(k) clearance for the RANDOX BARITURATES ASSAY. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on May 25, 2011, 666 days after receiving the submission on July 28, 2009.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K092268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2009 |
| Decision Date | May 25, 2011 |
| Days to Decision | 666 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |