The following data is part of a premarket notification filed by Ibl-hamburg Gmbh with the FDA for Cortisol Elisa.
| Device ID | K062626 |
| 510k Number | K062626 |
| Device Name: | CORTISOL ELISA |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | IBL-HAMBURG GMBH FLUGHAFENSTRASSE 52A Hamburg, DE D-22335 |
| Contact | Victor Herbst |
| Correspondent | Victor Herbst IBL-HAMBURG GMBH FLUGHAFENSTRASSE 52A Hamburg, DE D-22335 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2006-12-20 |
| Summary: | summary |