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FDA 510(k) Application Details - K061990
Device Classification Name
Albumin, Antigen, Antiserum, Control
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510(K) Number
K061990
Device Name
Albumin, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,, DE 19714 US
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Contact
KATHLEEN DRAY-LYONS
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Regulation Number
866.5040
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Classification Product Code
DCF
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More FDA Info for this Product Code
Date Received
07/13/2006
Decision Date
09/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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