The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cortisol Ii, Cortisol Ii Calset.
| Device ID | K152227 |
| 510k Number | K152227 |
| Device Name: | Elecsys Cortisol II, Cortisol II CalSet |
| Classification | Fluorometric, Cortisol |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-04-27 |
| Summary: | summary |