Name: Predicase
Price: 199 USD

K-number	K021316
Device name	ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
Applicant	Genzyme Corp.
Product code	LBS
Device class	Class I
Decision date	Jul 25, 2002
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

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