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FDA 510(k) Application Details - K965076
Device Classification Name
Assay, Heparin
More FDA Info for this Device
510(K) Number
K965076
Device Name
Assay, Heparin
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact
RON SANYAL
Other 510(k) Applications for this Contact
Regulation Number
864.7525
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Classification Product Code
KFF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/1996
Decision Date
03/18/1997
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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