The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cortisol Test System.
| Device ID | K070788 |
| 510k Number | K070788 |
| Device Name: | ELECSYS CORTISOL TEST SYSTEM |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-22 |
| Decision Date | 2007-10-05 |
| Summary: | summary |