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

Name: FDA 510(k) clearance K050625
Creator: U.S. Food and Drug Administration
Published: 2005-04-26

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. Device class: 2.

Clearance details

Applicant: Sweden Diagnostics (Germany) GmbH
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2005-03-11
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

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