510(k) K080017 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
VIDAS AFP ASSAY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 26, 2008 |
| Received | Jan 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080017
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.