The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Synelisa Cortisol.
| Device ID | K931177 |
| 510k Number | K931177 |
| Device Name: | SYNELISA CORTISOL |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellerman |
| Correspondent | Gottfried Kellerman ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-09-27 |