K-number	K131605
Device name	ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
Applicant	Roche Diagnostics
Product code	LFZ
Device class	Class II
Decision date	Feb 28, 2014
Decision	Substantially Equivalent
Regulation	866.3175

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View the full FDA submission: accessdata.fda.gov

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ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

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