Device Classification Name |
counter, differential cell
|
510(k) Number |
K021241 |
Device Name |
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I |
Applicant |
SYSMEX CORPORATION OF AMERICA |
6699 WILDLIFE WAY |
LONG GROVE,
IL
60047 -9596
|
|
Applicant Contact |
NINA M GAMPERLING' |
Correspondent |
SYSMEX CORPORATION OF AMERICA |
6699 WILDLIFE WAY |
LONG GROVE,
IL
60047 -9596
|
|
Correspondent Contact |
NINA M GAMPERLING' |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 04/19/2002 |
Decision Date | 06/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|