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FDA 510(k) Application Details - K020496
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K020496
Device Name
Counter, Differential Cell
Applicant
SYSMEX CORPORATION OF AMERICA
6699 WILDLIFE WAY
LONG GROVE, IL 60047-9596 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
02/14/2002
Decision Date
04/12/2002
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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