K-number	K012399
Device name	MODIFICATION TO ELECSYS FSH II CALSET
Applicant	Roche Diagnostics Corp.
Product code	JIT
Device class	Class II
Decision date	Aug 24, 2001
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ELECSYS FSH II CALSET

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