510(k) K093957 ยท OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 18, 2010 |
| Received | Dec 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093957
No recall in the FDA data names this 510(k).
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