K-number	K130337
Device name	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
Applicant	Randox Laboratories Limited
Product code	JJY
Device class	Class I
Decision date	Jun 19, 2013
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3

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