Device Classification Name |
diluent, blood cell
|
510(k) Number |
K881130 |
Device Name |
CELL-DYN ISOTONIC DILUENT |
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 | 864.8200
|
Classification Product Code |
|
Date Received | 03/16/1988 |
Decision Date | 03/31/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|