K060586 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY, VANCOMYCIN. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 11, 2006, 65 days after receiving the submission on March 7, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K060586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2006 |
| Decision Date | May 11, 2006 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |