K-number	K043318
Device name	MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
Applicant	Roche Diagnostics Corp.
Product code	CGN
Device class	Class II
Decision date	Dec 23, 2004
Decision	Substantially Equivalent
Regulation	862.1295

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MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY

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