510(k) K041866 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Sep 29, 2004 |
| Received | Jul 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041866
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.