The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Adva Centaur Testosterone Ii (tstii), Adva Centaur Testosterone Ii (tstii) Master Curve Material, Advia Centaur Shbg, Advia Centaur Shbg Calibrator, Advia Centaur Shbg Master Curve Material.
| Device ID | K151986 |
| 510k Number | K151986 |
| Device Name: | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material |
| 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 |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2016-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414603407 | K151986 | 000 |
| 00630414580654 | K151986 | 000 |
| 00630414591131 | K151986 | 000 |
| 00630414591148 | K151986 | 000 |
| 00630414591155 | K151986 | 000 |
| 00630414599854 | K151986 | 000 |
| 00630414600215 | K151986 | 000 |
| 00630414600222 | K151986 | 000 |
| 00630414600239 | K151986 | 000 |
| 00630414603391 | K151986 | 000 |
| 00630414293752 | K151986 | 000 |
| 00630414293813 | K151986 | 000 |
| 00630414599861 | K151986 | 000 |
| 00630414294285 | K151986 | 000 |