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FDA 510(k) Application Details - K100489
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K100489
Device Name
Counter, Differential Cell
Applicant
BECKMAN COULTER CELLULAR
11800 SW 147 AVENUE
MS 31 BO6
MIAMI, FL 33196-2500 US
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Contact
JEANNE ROSCOE
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
02/19/2010
Decision Date
10/26/2010
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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