K011303 is an FDA 510(k) clearance for the RANDOX PHENOBARBITAL. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on July 2, 2001, 63 days after receiving the submission on April 30, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K011303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2001 |
| Decision Date | July 02, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |