510(k) K063347— AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NHX
Advisory panel: Immunology
Date received: 2006-11-06
Decision date: 2007-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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