K-number	K010237
Device name	ELECSYS HCG+B CALCHECK
Applicant	Roche Diagnostics Corp.
Product code	JJX
Device class	Class I
Decision date	Feb 14, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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ELECSYS HCG+B CALCHECK

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