AXIS-SHIELD ACVTIVE-B12— 510(k) K121946

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K121946 for AXIS-SHIELD ACVTIVE-B12, Substantially Equivalent on 2013-03-22. Applicant: Axis-Shield Diagnostics, Ltd..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2012-07-03
Decision date: 2013-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

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