510(k) K152155 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ARCHITECT 2nd Generation Testosterone
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 17, 2015 |
| Received | Aug 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152155
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.