K-number	K131244
Device name	ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
Applicant	Roche Diagnostics
Product code	CEC
Device class	Class II
Decision date	Jan 27, 2014
Decision	Substantially Equivalent
Regulation	862.1695

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

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