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FDA 510(k) Application Details - K041438
Device Classification Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K041438
Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK, DE 19714-6101 US
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Contact
KATHLEEN DRAYLYONS
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Regulation Number
864.7320
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Classification Product Code
DAP
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More FDA Info for this Product Code
Date Received
06/01/2004
Decision Date
08/11/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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