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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K050665
Device Name N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500 M.S. 514; Pox 6101
Newark,  DE  19714 -6101
Applicant Contact DONNA A WOLF
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500 M.S. 514; Pox 6101
Newark,  DE  19714 -6101
Correspondent Contact DONNA A WOLF
Regulation Number866.5240
Classification Product Code
CZW  
Subsequent Product Code
DBI  
Date Received03/15/2005
Decision Date 05/02/2005
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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