K-number	K001032
Device name	RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
Applicant	Otsuka Pharmaceutical Co., Ltd.
Product code	CHH
Device class	Class I
Decision date	Jul 24, 2000
Decision	Substantially Equivalent
Regulation	862.1175

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View the full FDA submission: accessdata.fda.gov

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RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

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