Name: Predicase
Price: 199 USD

K-number	K082340
Device name	ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
Applicant	Roche Diagnostics Corp.
Product code	CGN
Device class	Class II
Decision date	Jun 19, 2009
Decision	Substantially Equivalent
Regulation	862.1295

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Source

View the full FDA submission: accessdata.fda.gov

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ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS

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