K-number	K131556
Device name	DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
Applicant	Diazyme Laboratories
Product code	JIT
Device class	Class II
Decision date	Jun 26, 2013
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

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