K-number	K003969
Device name	ELECSYS CA 125 II CALSET
Applicant	Roche Diagnostics Corp.
Product code	JIS
Device class	Class II
Decision date	Jan 12, 2001
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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ELECSYS CA 125 II CALSET

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