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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K040811
Device Name VARELISA SSDNA ANTIBODIES, MODEL 14896
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 Number866.5100
Classification Product Code
LRM  
Date Received03/29/2004
Decision Date 05/13/2004
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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