Device Classification Name |
counter, differential cell
|
510(k) Number |
K943894 |
Device Name |
SYSMEX K-4500 |
Applicant |
SYSMEX CORP. |
GILMER RD. |
6699 RFD |
LONG GROVE,
IL
60047 -9596
|
|
Applicant Contact |
JEME WALLACE |
Correspondent |
SYSMEX CORP. |
GILMER RD. |
6699 RFD |
LONG GROVE,
IL
60047 -9596
|
|
Correspondent Contact |
JEME WALLACE |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 08/09/1994 |
Decision Date | 02/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|