The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Br.
| Device ID | K193489 |
| 510k Number | K193489 |
| Device Name: | ADVIA Centaur BR |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598055 | K193489 | 000 |
| 00630414598048 | K193489 | 000 |
| 00630414294049 | K193489 | 000 |
| 00630414204772 | K193489 | 000 |
| 00630414196664 | K193489 | 000 |
| 00630414196657 | K193489 | 000 |