K-number	K001004
Device name	WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
Applicant	Wako Chemicals USA, Inc.
Product code	JIS
Device class	Class II
Decision date	Jun 1, 2000
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

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