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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
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