510(k) K172133— ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2017-07-14
Decision date: 2017-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Dundee, GB

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