K032279 is an FDA 510(k) clearance for the ONLINE TDM AMIKA. This device is classified as a Amikacin Serum Assay (Class II - Special Controls, product code KLP).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 10, 2003, 78 days after receiving the submission on July 24, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K032279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2003 |
| Decision Date | October 10, 2003 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KLP — Amikacin Serum Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |