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510(k) K162173

Elecsys CYFRA 21-1 CalCheck 5 by Roche Diagnostics — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
August 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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