The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Ft4, Advia Centaur T4.
| Device ID | K132249 |
| 510k Number | K132249 |
| Device Name: | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Mattew Gee |
| Correspondent | Mattew Gee Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-19 |
| Decision Date | 2013-09-13 |
| Summary: | summary |