K-number	K890023
Device name	HDL CHOLESTEROL REAGENT (PTA/MGCL2)
Applicant	Sigma Diagnostics, Inc.
Product code	LBR
Device class	Class I
Decision date	Feb 17, 1989
Decision	Substantially Equivalent
Regulation	862.1475

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View the full FDA submission: accessdata.fda.gov

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HDL CHOLESTEROL REAGENT (PTA/MGCL2)

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