K-number	K113747
Device name	RANDOX OPIATES ASSAY
Applicant	Randox Laboratories Limited
Product code	DJG
Device class	Class II
Decision date	Aug 24, 2012
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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RANDOX OPIATES ASSAY

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