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FDA 510(k) Application Details - K143348
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K143348
Device Name
Counter, Differential Cell
Applicant
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Mindray Building, Keji 12th Road South
High-tech Industrial Park
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Tan Chuanbin
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
11/21/2014
Decision Date
08/21/2015
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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