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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 K020758
Device Name VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
Applicant
Pharmacia Deutschland GmbH
Munzingerstrasse 7
Freiburg,  DE
Applicant Contact MICHARL LINSS
Correspondent
Pharmacia Deutschland GmbH
Munzingerstrasse 7
Freiburg,  DE
Correspondent Contact MICHARL LINSS
Regulation Number866.5660
Classification Product Code
MID  
Date Received03/07/2002
Decision Date 05/02/2002
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
Recalls CDRH Recalls
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