K-number	K032811
Device name	CEDIA VANCOMYCIN ASSAY
Applicant	Microgenics Corp.
Product code	LEH
Device class	Class II
Decision date	Nov 24, 2003
Decision	Substantially Equivalent
Regulation	862.3950

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View the full FDA submission: accessdata.fda.gov

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CEDIA VANCOMYCIN ASSAY

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