K021316

Substantially Equivalent

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

Applicant: Genzyme Corp.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2002-04-25
Decision date: 2002-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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