The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Ca 15-3 Assay.
| Device ID | K192777 |
| 510k Number | K192777 |
| Device Name: | ADVIA Centaur CA 15-3 Assay |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Anoop Joy |
| Correspondent | Anoop Joy Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-22 |