K-number	K051292
Device name	ELECSYS RBC FOLATE HEMOLYZED REAGENT
Applicant	Roche Diagnostics Corp.
Product code	CGN
Device class	Class II
Decision date	Jun 17, 2005
Decision	Substantially Equivalent
Regulation	862.1295

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View the full FDA submission: accessdata.fda.gov

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ELECSYS RBC FOLATE HEMOLYZED REAGENT

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