Device Classification Name |
counter, differential cell
|
510(k) Number |
K143577 |
Device Name |
XW-100 Automated Hematology Analyzer, XW QC CHECK |
Applicant |
SYSMEX AMERICA, INC. |
577 Aptakisic Road |
Lincolnshire,
IL
60069
|
|
Applicant Contact |
Peter Shearstone |
Correspondent |
SYSMEX AMERICA, INC. |
577 Aptakisic Road |
Lincolnshire,
IL
60069
|
|
Correspondent Contact |
Peter Shearstone |
Regulation Number | 864.5220
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/17/2014 |
Decision Date | 10/12/2015 |
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
|
|
|