K-number	K112790
Device name	AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	LPS
Device class	Class II
Decision date	May 7, 2012
Decision	Substantially Equivalent
Regulation	862.1377

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AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

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