The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ft4 Ii Assay, Elecsys Ft4 Ii Calset.
| Device ID | K131244 |
| 510k Number | K131244 |
| Device Name: | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Edie Eads |
| Correspondent | Edie Eads Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2014-01-27 |
| Summary: | summary |