Device Classification Name |
counter, differential cell
|
510(k) Number |
K890491 |
Device Name |
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER |
Applicant |
ABBOTT DIAGNOSTICS |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
RUTH M BECKER |
Correspondent |
ABBOTT DIAGNOSTICS |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
RUTH M BECKER |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 01/31/1989 |
Decision Date | 04/18/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|