FDA 510(k) Applications for Medical Device Product Code "OVK"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K100831 | FUJIREBIO DIAGNOSTICS, INC | CYFRA 21-1 EIA MODEL 211-10 | 05/26/2011 |
| K160915 | ROCHE DIAGNOSTICS | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | 12/14/2016 |
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