VARELISA RECOMBI ANA PROFILE, MODEL 18496— 510(k) K050625

Substantially Equivalent

Sweden Diagnostics (Germany) GmbH

FDA 510(k) clearance K050625 for VARELISA RECOMBI ANA PROFILE, MODEL 18496, Substantially Equivalent on 2005-04-26. Applicant: Sweden Diagnostics (Germany) GmbH.

Clearance details

Applicant: Sweden Diagnostics (Germany) GmbH
Product code: Code LJM
Advisory panel: Immunology
Date received: 2005-03-11
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

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