510(k) K100321 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 12, 2011 |
| Received | Feb 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100321
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.