The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Cortisol Test System.
| Device ID | K021218 |
| 510k Number | K021218 |
| Device Name: | ELECSYS CORTISOL TEST SYSTEM |
| Classification | Fluorometric, Cortisol |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2002-09-09 |
| Summary: | summary |