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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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