K-number	K990581
Device name	DIRECT HDL-CHOLESTEROL REAGENT
Applicant	Kamiya Biomedical Co.
Product code	LBS
Device class	Class I
Decision date	Jun 18, 1999
Decision	Substantially Equivalent
Regulation	862.1475

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View the full FDA submission: accessdata.fda.gov

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DIRECT HDL-CHOLESTEROL REAGENT

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