K-number	K091601
Device name	ELECYS ANTI-CCP CALCHECK
Applicant	Roche Diagnostics Corp.
Product code	JJX
Device class	Class I
Decision date	Sep 25, 2009
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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ELECYS ANTI-CCP CALCHECK

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