Device Classification Name |
counter, differential cell
|
510(k) Number |
K800533 |
Device Name |
ADD OF RETICULOCYTE COUNT/CAPABILITIES |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 03/07/1980 |
Decision Date | 04/04/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|