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FDA 510(k) Application Details - K042941
Device Classification Name
Plasma, Control, Normal
More FDA Info for this Device
510(K) Number
K042941
Device Name
Plasma, Control, Normal
Applicant
DADE BEHRING, INC.
GLASCO B500 M.S. 514
P.O. BOX 6101
NEWARK, DE 19714-6101 US
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Contact
RADAMES RIESGO
Other 510(k) Applications for this Contact
Regulation Number
864.5425
More FDA Info for this Regulation Number
Classification Product Code
GIZ
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More FDA Info for this Product Code
Date Received
10/25/2004
Decision Date
12/02/2004
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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