K-number	K102269
Device name	ELECSYS IGE CALCHECK 5
Applicant	Roche Diagnostics
Product code	JJX
Device class	Class I
Decision date	Oct 7, 2010
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS IGE CALCHECK 5

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