The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Cortisol (cor) Assy.
| Device ID | K142723 |
| 510k Number | K142723 |
| Device Name: | ADVIA Centaur Cortisol (COR) Assy |
| Classification | Fluorometric, Cortisol |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 -5097 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 -5097 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-23 |
| Decision Date | 2015-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414602950 | K142723 | 000 |
| 00630414602943 | K142723 | 000 |
| 00630414598659 | K142723 | 000 |
| 00630414598642 | K142723 | 000 |
| 00630414294155 | K142723 | 000 |