ARCHITECT Active-B12 (Holotranscobalamin)— 510(k) K233541

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K233541 for ARCHITECT Active-B12 (Holotranscobalamin), Substantially Equivalent on 2024-07-31. Applicant: Axis-Shield Diagnostics, Ltd..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2023-11-03
Decision date: 2024-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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