K-number	K143534
Device name	Elecsys CA-125 II assay
Applicant	Roche Professional Diagnostics
Product code	LTK
Device class	Class II
Decision date	Aug 6, 2015
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys CA-125 II assay

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