K-number	K143284
Device name	Elecsys Estradiol III Calcheck
Applicant	Roche Diagnostics
Product code	JJX
Device class	Class I
Decision date	Dec 16, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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Elecsys Estradiol III Calcheck

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