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FDA 510(k) Application Details - K170353
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K170353
Device Name
Counter, Differential Cell
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue du Caducee BP 7290
Montpellier Cedex 4 34184 FR
Other 510(k) Applications for this Company
Contact
Caroline Ferrer
Other 510(k) Applications for this Contact
Regulation Number
864.5220
More FDA Info for this Regulation Number
Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/2017
Decision Date
11/01/2017
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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