K173857 is an FDA 510(k) clearance for the Elecsys Tacrolimus. This device is classified as a Enzyme Immunoassay, Tracrolimus (Class II - Special Controls, product code MLM).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 6, 2018, 321 days after receiving the submission on December 20, 2017.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1678.
| 510(k) Number | K173857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2017 |
| Decision Date | November 06, 2018 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MLM — Enzyme Immunoassay, Tracrolimus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1678 |