K152245 is an FDA 510(k) clearance for the ONLINE TDM Vancomycin Gen.3. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on January 8, 2016, 151 days after receiving the submission on August 10, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K152245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2015 |
| Decision Date | January 08, 2016 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |