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FDA 510(k) Application Details - K090346
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K090346
Device Name
Counter, Differential Cell
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
Ernest Joseph
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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
02/11/2009
Decision Date
07/28/2010
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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