Device Classification Name |
counter, differential cell
|
510(k) Number |
BK210559 |
Tradename |
Sysmex XN-10 Automated Hematology Analyzer
|
Device Name |
Counter, Differential Cell |
Original Applicant |
Sysmex America, Inc. |
577 aptakisic rd |
lincolnshire,
IL
60069
|
|
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 03/04/2021 |
Decision Date | 05/27/2021 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
Yes
|
|
|