The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Cortisol (cor).
| Device ID | K192788 |
| 510k Number | K192788 |
| Device Name: | ADVIA Centaur Cortisol (COR) |
| Classification | Fluorometric, Cortisol |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Ian Thompson |
| Correspondent | Ian Thompson Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-25 |
| Summary: | summary |