K-number	K092585
Device name	ELECSYS RUBELLA IGGA CALCHECK 5
Applicant	Roche Diagnostics
Product code	JJX
Device class	Class I
Decision date	Oct 30, 2009
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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ELECSYS RUBELLA IGGA CALCHECK 5

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