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FDA 510(k) Application Details - K955857
Device Classification Name
Complement C3, Antigen, Antiserum, Control
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510(K) Number
K955857
Device Name
Complement C3, Antigen, Antiserum, Control
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA 02090 US
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Contact
KATHLEEN DRAY-LYONS
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Regulation Number
866.5240
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Classification Product Code
CZW
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More FDA Info for this Product Code
Date Received
12/27/1995
Decision Date
02/21/1996
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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