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FDA 510(k) Application Details - K102644
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K102644
Device Name
Counter, Differential Cell
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
GERARD SADRAKULA
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
09/14/2010
Decision Date
11/23/2011
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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