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FDA 510(k) Application Details - K081495
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K081495
Device Name
Counter, Differential Cell
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA, CA 95054 US
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Contact
MICHELLE B ROEDING
Other 510(k) Applications for this Contact
Regulation Number
864.5220
More FDA Info for this Regulation Number
Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/2008
Decision Date
02/04/2009
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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