The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Ca 125ii.
| Device ID | K200199 |
| 510k Number | K200199 |
| Device Name: | ADVIA Centaur CA 125II |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-04-06 |