K-number	K092322
Device name	ELECSYS RUBELLA IGM IMMUNOASSAY
Applicant	Roche Diagnostics
Product code	LFX
Device class	Class II
Decision date	Mar 12, 2010
Decision	Substantially Equivalent
Regulation	866.3510

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View the full FDA submission: accessdata.fda.gov

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ELECSYS RUBELLA IGM IMMUNOASSAY

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