K072395

Substantially Equivalent

DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS

Applicant: Diazyme Laboratories
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2007-08-27
Decision date: 2008-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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