510(k) K153577 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
FREND Testosterone Test System
| Applicant | Nanoentek USA, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Dec 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153577
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.