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FDA 510(k) Application Details - K160915
Device Classification Name
More FDA Info for this Device
510(K) Number
K160915
Device Name
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Applicant
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250 US
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Contact
Adam Clark
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Regulation Number
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Classification Product Code
OVK
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More FDA Info for this Product Code
Date Received
04/01/2016
Decision Date
12/14/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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