510(k) K112443— ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2011-08-24
Decision date: 2011-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

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