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FDA 510(k) Application Details - K974776
Device Classification Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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510(K) Number
K974776
Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact
RON SANYAL
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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
12/22/1997
Decision Date
04/16/1998
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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