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FDA 510(k) Application Details - K020979
Device Classification Name
Instrument, Coagulation, Automated
More FDA Info for this Device
510(K) Number
K020979
Device Name
Instrument, Coagulation, Automated
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK, DE 19714 US
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Contact
REBECCA S AYASH
Other 510(k) Applications for this Contact
Regulation Number
864.5400
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Classification Product Code
GKP
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More FDA Info for this Product Code
Date Received
03/26/2002
Decision Date
06/27/2002
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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