K012593

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LBR
Advisory panel: Clinical Chemistry
Date received: 2001-08-10
Decision date: 2001-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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