The following data is part of a premarket notification filed by Siemens Healthcare Disgnostics Inc. with the FDA for Advia Centaur Cea Assay.
| Device ID | K200215 |
| 510k Number | K200215 |
| Device Name: | ADVIA Centaur CEA Assay |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | Siemens Healthcare Disgnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Contact | Mey Lyn Vasquez |
| Correspondent | Mey Lyn Vasquez Siemens Healthcare Disgnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-04-13 |