Device Classification Name |
counter, differential cell
|
510(k) Number |
K182389 |
Device Name |
Sysmex XN-L Automated Hematology Analyzer |
Applicant |
Sysmex America, Inc. |
577 Aptakisic Road. |
Lincolnshire,
IL
60069
|
|
Applicant Contact |
Sharita Brooks |
Correspondent |
Sysmex America, Inc. |
577 Aptakisic Road. |
Lincolnshire,
IL
60069
|
|
Correspondent Contact |
Sharita Brooks |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 09/04/2018 |
Decision Date | 01/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|