The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Cortisol Test System, Addition Of Saliva Sample Type.
| Device ID | K043175 |
| 510k Number | K043175 |
| Device Name: | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2004-11-24 |
| Summary: | summary |