K-number	K140393
Device name	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
Applicant	Randox Laboratories Limited
Product code	JJY
Device class	Class I
Decision date	Mar 25, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

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