510(k) K020348— ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2002-02-04
Decision date: 2002-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

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