K030360 is an FDA 510(k) clearance for the RANDOX EVIDENCE. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on December 23, 2003, 323 days after receiving the submission on February 3, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K030360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2003 |
| Decision Date | December 23, 2003 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |