The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Testosterone Ii (tstii), Advia Centaur Shbg.
| Device ID | K191533 |
| 510k Number | K191533 |
| Device Name: | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Paul Dasilva |
| Correspondent | Paul Dasilva Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-08-28 |