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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K041043
Device Name VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
Applicant
Pharmacia Deutschland GmbH
Munzinger Strasse 7
Freiburg Im Breisgau,  DE 79111
Applicant Contact MICHAEL LINSS
Correspondent
Pharmacia Deutschland GmbH
Munzinger Strasse 7
Freiburg Im Breisgau,  DE 79111
Correspondent Contact MICHAEL LINSS
Regulation Number866.5660
Classification Product Code
MOB  
Date Received04/22/2004
Decision Date 07/02/2004
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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