K100831

Substantially Equivalent

CYFRA 21-1 EIA MODEL 211-10

Applicant: Fujirebio Diagnostics,Inc.
Product code: OVK
Advisory panel: Immunology
Date received: 2010-03-24
Decision date: 2011-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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