K-number	K072523
Device name	DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
Applicant	General Atomics
Product code	LBR
Device class	Class I
Decision date	Jan 22, 2008
Decision	Substantially Equivalent
Regulation	862.1475

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DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

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