K033884 is an FDA 510(k) clearance for the RANDOX AMIKACIN. This device is classified as a Radioimmunoassay, Amikacin (Class II - Special Controls, product code KLQ).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on June 9, 2004, 177 days after receiving the submission on December 15, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K033884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2003 |
| Decision Date | June 09, 2004 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KLQ — Radioimmunoassay, Amikacin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |