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FDA 510(k) Application Details - K153538
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K153538
Device Name
Counter, Differential Cell
Applicant
Immudex Aps
Fruebjergvej 3
Copenhagen 2100 DK
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Contact
Liselotte Brix
Other 510(k) Applications for this Contact
Regulation Number
864.5220
More FDA Info for this Regulation Number
Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
12/10/2015
Decision Date
03/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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