510(k) K151986 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 29, 2016 |
| Received | Jul 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151986
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.