K-number	K173195
Device name	DRI Hydrocodone Assay
Applicant	Microgenics Corporation
Product code	DJG
Device class	Class II
Decision date	Feb 13, 2018
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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DRI Hydrocodone Assay

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