510(k) K191533 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 28, 2019 |
| Received | Jun 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191533
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.