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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 K040449
Device Name VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
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
Predetermined Change
Control Plan Authorized		 No
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