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FDA 510(k) Application Details - K955673
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K955673
Device Name
Counter, Differential Cell
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA, CA 95054 US
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Contact
JANICE E BROWN
Other 510(k) Applications for this Contact
Regulation Number
864.5220
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Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
11/06/1995
Decision Date
05/20/1996
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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