510(k) K142895 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 21, 2015 |
| Received | Oct 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142895
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.