K-number	K220456
Device name	Elecsys FT4 IV
Applicant	Roche Diagnostics
Product code	CEC
Device class	Class II
Decision date	Apr 7, 2023
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 IV

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