K-number	K101742
Device name	THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
Applicant	Microgenics Corp.
Product code	DIO
Device class	Class II
Decision date	Apr 8, 2011
Decision	Substantially Equivalent
Regulation	862.3250

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Source

View the full FDA submission: accessdata.fda.gov

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THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

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