K-number	K043320
Device name	MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
Applicant	Roche Diagnostics Corp.
Product code	JJX
Device class	Class I
Decision date	Dec 17, 2004
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

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