Device Classification Name |
counter, differential cell
|
510(k) Number |
K020496 |
Device Name |
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY |
Applicant |
SYSMEX CORPORATION OF AMERICA |
6699 WILDLIFE WAY |
LONG GROVE,
IL
60047 -9596
|
|
Applicant Contact |
NINA GAMPERLING |
Correspondent |
SYSMEX CORPORATION OF AMERICA |
6699 WILDLIFE WAY |
LONG GROVE,
IL
60047 -9596
|
|
Correspondent Contact |
NINA GAMPERLING |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 02/14/2002 |
Decision Date | 04/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|