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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K042629
Device Name VARELISA SM ANTIBODIES, MODEL 18296
Applicant
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Applicant Contact SABINE KLUGBAUER
Correspondent
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Correspondent Contact SABINE KLUGBAUER
Regulation Number866.5100
Classification Product Code
LKP  
Date Received09/27/2004
Decision Date 12/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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