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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K023433
Device Name VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
Applicant
Pharmacia Diagnostics GmbH & Co. KG
Munzingerstrasse 7
Freiburg,  DE D-79111
Applicant Contact MICHAEL LINSS
Correspondent
Pharmacia Diagnostics GmbH & Co. KG
Munzingerstrasse 7
Freiburg,  DE D-79111
Correspondent Contact MICHAEL LINSS
Regulation Number866.5660
Classification Product Code
MID  
Date Received10/15/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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