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FDA 510(k) Application Details - K053075
Device Classification Name
Transferrin, Antigen, Antiserum, Control
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510(K) Number
K053075
Device Name
Transferrin, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,, DE 19714 US
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Contact
KATHLEEN A DRAY-LYONS
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Regulation Number
866.5880
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Classification Product Code
DDG
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More FDA Info for this Product Code
Date Received
11/01/2005
Decision Date
03/16/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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