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FDA 510(k) Application Details - K994296
Device Classification Name
Complement C3, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K994296
Device Name
Complement C3, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
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Contact
RICHARD M VAUGHT
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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
12/21/1999
Decision Date
03/01/2000
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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