K-number	K043264
Device name	LDL-EX SEIKEN ASSAY KIT
Applicant	Denka Seiken Co., Ltd.
Product code	MRR
Device class	Class I
Decision date	Jan 26, 2005
Decision	Substantially Equivalent
Regulation	862.1475

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View the full FDA submission: accessdata.fda.gov

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LDL-EX SEIKEN ASSAY KIT

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