FDA 510(k) Applications Submitted by AXIS-SHIELD DIAGNOSTICS LIMITED

FDA 510(k) Number	Submission Date	Device Name	Applicant
K182012	07/27/2018	ADVIA Centaur Calcitonin (CALCT) assay	Axis-Shield Diagnostics Limited
K183088	11/06/2018	ADVIA Centaur Erythropoietin (EPO) assay	Axis-Shield Diagnostics Limited
K160757	03/18/2016	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)	AXIS-SHIELD DIAGNOSTICS LIMITED