510(k) K112624 ยท OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 10, 2012 |
| Received | Sep 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112624
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.