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FDA 510(k) Applications Submitted by ADAM CLARK
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160729
03/16/2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Roche Diagnostics
K160915
04/01/2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
ROCHE DIAGNOSTICS
K150955
04/09/2015
Elecsys Progesterone III Cal Check 5
ROCHE DIAGNOSTICS
K162173
08/03/2016
Elecsys CYFRA 21-1 CalCheck 5
Roche Diagnostics
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