The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ft4 Iii.
| Device ID | K181233 |
| 510k Number | K181233 |
| Device Name: | Elecsys FT4 III |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Reanna Toney |
| Correspondent | Reanna Toney Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-09 |
| Decision Date | 2018-09-18 |
| Summary: | summary |