510(k) K151378 ยท OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Nov 24, 2015 |
| Received | May 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151378
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.