K-number	K162173
Device name	Elecsys CYFRA 21-1 CalCheck 5
Applicant	Roche Diagnostics
Product code	JJX
Device class	Class I
Decision date	Jan 12, 2017
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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Elecsys CYFRA 21-1 CalCheck 5

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