VARELISA SM ANTIBODIES, MODEL 18296— 510(k) K042629

Name: FDA 510(k) clearance K042629
Creator: U.S. Food and Drug Administration
Published: 2004-12-08

Substantially Equivalent

Sweden Diagnostics (Germany) GmbH

FDA 510(k) clearance K042629 for VARELISA SM ANTIBODIES, MODEL 18296, Substantially Equivalent on 2004-12-08. Applicant: Sweden Diagnostics (Germany) GmbH. Device class: 2.

Clearance details

Applicant: Sweden Diagnostics (Germany) GmbH
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2004-09-27
Decision date: 2004-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

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