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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K972840
Device Name N ANTISERUM TO HUMAN TRANSFERRIN
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact Ruth Forstadt
Correspondent
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact Ruth Forstadt
Regulation Number866.5880
Classification Product Code
DDG  
Date Received08/01/1997
Decision Date 10/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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