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FDA 510(k) Application Details - K022290
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K022290
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
DADE BEHRING, INC.
514 GBC DR.
NEWARK, DE 19702 US
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Contact
DONNA A WOLF
Other 510(k) Applications for this Contact
Regulation Number
864.7290
More FDA Info for this Regulation Number
Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
07/15/2002
Decision Date
08/27/2002
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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