510(k) K080094 ยท DHA System, Test, Human Chorionic Gonadotropin
OLYMPUS TOTAL BHCG TEST SYSTEN
| Applicant | Olympus Life Science Research Europa GmbH (Europa), Irving TX, US |
| Decision | Substantially Equivalent, Sep 3, 2008 |
| Received | Jan 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080094
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.