Lumipulse G CA15-3— 510(k) K192524

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K192524 for Lumipulse G CA15-3, Substantially Equivalent on 2020-09-04. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2019-09-13
Decision date: 2020-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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