AXIS-SHIELD ANTI-CCP— 510(k) K110296

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K110296 for AXIS-SHIELD ANTI-CCP, Substantially Equivalent on 2011-08-18. Applicant: Axis-Shield Diagnostics, Ltd..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NHX
Advisory panel: Immunology
Date received: 2011-02-01
Decision date: 2011-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

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