K-number	K081338
Device name	ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
Applicant	Roche Diagnostics
Product code	NHX
Device class	Class II
Decision date	Sep 11, 2008
Decision	Substantially Equivalent
Regulation	866.5775

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ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

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