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FDA 510(k) Application Details - K022976
Device Classification Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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510(K) Number
K022976
Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG 500, MS 514 P.O.BOX 6101
NEWARK, DE 19714-6101 US
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Contact
RICHARD M VAUGHT
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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
09/06/2002
Decision Date
01/16/2003
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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