K-number	K192943
Device name	CEDIA Heroin Metabolite (6-AM) assay
Applicant	Microgenics Corporation
Product code	DJG
Device class	Class II
Decision date	Dec 16, 2019
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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CEDIA Heroin Metabolite (6-AM) assay

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