The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Tacrolimus.
| Device ID | K173857 |
| 510k Number | K173857 |
| Device Name: | Elecsys Tacrolimus |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Khoa Tran |
| Correspondent | Khoa Tran Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-11-06 |
| Summary: | summary |