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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cytokeratin Fragments 21-1 Eia Kit
510(k) Number K160915
Device Name Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Adam Clark
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Adam Clark
Regulation Number866.6010
Classification Product Code
OVK  
Subsequent Product Codes
JIT   JJX  
Date Received04/01/2016
Decision Date 12/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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