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FDA 510(k) Application Details - K051459
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K051459
Device Name
Counter, Differential Cell
Applicant
SYSMEX AMERICA, INC.
ONE NELSON C. WHITE PARKWAY
MUNDELEIN, IL 60060 US
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Contact
NINA GAMPERLING
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
06/02/2005
Decision Date
09/23/2005
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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