ADVIA Centaur Erythropoietin (EPO) assay— 510(k) K183088

Substantially Equivalent

Axis-Shield Diagnostics Limited

FDA 510(k) clearance K183088 for ADVIA Centaur Erythropoietin (EPO) assay, Substantially Equivalent on 2019-08-02. Applicant: Axis-Shield Diagnostics Limited.

Clearance details

Applicant: Axis-Shield Diagnostics Limited
Product code: Code GGT
Advisory panel: Hematology
Date received: 2018-11-06
Decision date: 2019-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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