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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,antibodies,b2 - glycoprotein i (b2 - gpi)
510(k) Number K040452
Device Name VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
Applicant
PHARMACIA DEUTSCHLAND GMBH
DIAGNOSTICS DIVISION
MUNZINGER STRASSE 7
FREIBURG,  DE D-79111
Applicant Contact MICHAEL LINSS
Correspondent
PHARMACIA DEUTSCHLAND GMBH
DIAGNOSTICS DIVISION
MUNZINGER STRASSE 7
FREIBURG,  DE D-79111
Correspondent Contact MICHAEL LINSS
Regulation Number866.5660
Classification Product Code
MSV  
Date Received02/20/2004
Decision Date 05/11/2004
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
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