K-number	K003967
Device name	CA 125 II CALCHECK
Applicant	Roche Diagnostics Corp.
Product code	JJX
Device class	Class I
Decision date	Jan 12, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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CA 125 II CALCHECK

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