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FDA 510(k) Applications Submitted by Axis-Shield Diagnostics Limited.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K153551
12/11/2015
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
Axis-Shield Diagnostics Limited.
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