K-number	K012319
Device name	RANDOX HUMAN ASSSAYED DRUG CONTROL
Applicant	Randox Laboratories, Ltd.
Product code	DIF
Device class	Class I
Decision date	Aug 24, 2001
Decision	Substantially Equivalent
Regulation	862.3280

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View the full FDA submission: accessdata.fda.gov

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RANDOX HUMAN ASSSAYED DRUG CONTROL

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