VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896— 510(k) K041354

Substantially Equivalent

Sweden Diagnostics (Germany) GmbH

FDA 510(k) clearance K041354 for VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896, Substantially Equivalent on 2004-07-16. Applicant: Sweden Diagnostics (Germany) GmbH.

Clearance details

Applicant: Sweden Diagnostics (Germany) GmbH
Product code: Code MST
Advisory panel: Immunology
Date received: 2004-05-20
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

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