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FDA 510(k) Application Details - K172604
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K172604
Device Name
Counter, Differential Cell
Applicant
Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire, IL 60069 US
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Contact
Michelle Abraham
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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
08/30/2017
Decision Date
11/06/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
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