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

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.

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.