K103676

Substantially Equivalent

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

Applicant: Fujirebio Diagnostics,Inc.
Product code: OIU
Advisory panel: Immunology
Date received: 2010-12-16
Decision date: 2011-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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