K-number	K171605
Device name	Elecsys CA 15-3 II
Applicant	Roche Diagnostics
Product code	MOI
Device class	Class II
Decision date	Feb 20, 2018
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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Elecsys CA 15-3 II

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