The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Estradiol Iii Calset.
| Device ID | K142021 |
| 510k Number | K142021 |
| Device Name: | Elecsys Estradiol III CalSet |
| Classification | Calibrator, Secondary |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2014-08-12 |
| Summary: | summary |