The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Testosterone (tsto).
| Device ID | K133491 |
| 510k Number | K133491 |
| Device Name: | ADVIA CENTAUR TESTOSTERONE (TSTO) |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-02-21 |
| Summary: | summary |