Device Classification Name |
counter, differential cell
|
510(k) Number |
K951496 |
Device Name |
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER |
Applicant |
ABBOTT LABORATORIES |
1825 WALNUT HILL LN. |
1920 & 1921 HURD DRIVE |
IRVIN,
TX
75038
|
|
Applicant Contact |
JANICE E BROWN |
Correspondent |
ABBOTT LABORATORIES |
1825 WALNUT HILL LN. |
1920 & 1921 HURD DRIVE |
IRVIN,
TX
75038
|
|
Correspondent Contact |
JANICE E BROWN |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 02/13/1995 |
Decision Date | 10/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|