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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-2-Macroglobulin, Antigen, Antiserum, Control
510(k) Number K053073
Device Name N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number866.5620
Classification Product Code
DEB  
Date Received11/01/2005
Decision Date 03/28/2006
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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