K142895

Substantially Equivalent

LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

Applicant: Fujirebio Diagnostics,Inc.
Product code: LTK
Advisory panel: Immunology
Date received: 2014-10-03
Decision date: 2015-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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