The following data is part of a premarket notification filed by Ibl International Gmbh with the FDA for Cortisol Saliva Luminescence Immunoassay.
| Device ID | K150528 |
| 510k Number | K150528 |
| Device Name: | Cortisol Saliva Luminescence Immunoassay |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | IBL INTERNATIONAL GMBH FLUGHAFENSTRASSE 52 A Hamburg, DE D-22335 |
| Contact | Nicola Kaiser |
| Correspondent | Nicola Kaiser IBL INTERNATIONAL GMBH FLUGHAFENSTRASSE 52 A Hamburg, DE D-22335 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-11-25 |
| Summary: | summary |