K-number	K010588
Device name	ELECSYSCA 15-3 II ASSAY
Applicant	Roche Diagnostics Corp.
Product code	MOI
Device class	Class II
Decision date	Mar 28, 2001
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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ELECSYSCA 15-3 II ASSAY

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