K-number	K012318
Device name	RANDOX THERAPEUTIC DRUG CALIBRATOR
Applicant	Randox Laboratories, Ltd.
Product code	DKB
Device class	Class II
Decision date	Sep 12, 2001
Decision	Substantially Equivalent
Regulation	862.3200

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View the full FDA submission: accessdata.fda.gov

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RANDOX THERAPEUTIC DRUG CALIBRATOR

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