K050419 is an FDA 510(k) clearance for the QMS VANCOMYCIN. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 1, 2005, 42 days after receiving the submission on February 18, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K050419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2005 |
| Decision Date | April 01, 2005 |
| Days to Decision | 42 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 |