Device Classification Name |
counter, differential cell
|
510(k) Number |
K112605 |
Device Name |
SYSMEX XN-SERIES |
Applicant |
SYSMEX AMERICA, INC. |
577 Aptakisic Rd |
Lincolnshire,
IL
60069
|
|
Applicant Contact |
SHARITA BROOKS |
Correspondent |
SYSMEX AMERICA, INC. |
577 Aptakisic Rd |
Lincolnshire,
IL
60069
|
|
Correspondent Contact |
SHARITA BROOKS |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 09/07/2011 |
Decision Date | 10/19/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|