K-number	K131999
Device name	HBA1C CONTROL, LEVEL 1 AND LEVEL 2
Applicant	Randox Laboratories, Ltd.
Product code	JJX
Device class	Class I
Decision date	Jul 26, 2013
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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HBA1C CONTROL, LEVEL 1 AND LEVEL 2

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