K-number	K103716
Device name	ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
Applicant	Roche Diagnostics
Product code	CGN
Device class	Class II
Decision date	May 12, 2011
Decision	Substantially Equivalent
Regulation	862.1295

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View the full FDA submission: accessdata.fda.gov

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ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

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