K-number	K011958
Device name	CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
Applicant	Denka Seiken'S
Product code	DCN
Device class	Class II
Decision date	Dec 4, 2001
Decision	Substantially Equivalent
Regulation	866.5270

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View the full FDA submission: accessdata.fda.gov

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CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

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