K013076 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS VANCOMYCIN REAGENT. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 12, 2001, 89 days after receiving the submission on September 14, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K013076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2001 |
| Decision Date | December 12, 2001 |
| Days to Decision | 89 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 |