K023784

Substantially Equivalent

RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER

Applicant: Hemagen Diagnostics, Inc.
Product code: LBR
Advisory panel: Clinical Chemistry
Date received: 2002-11-12
Decision date: 2002-12-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

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