Device Classification Name |
counter, differential cell
|
510(k) Number |
K981342 |
Device Name |
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY |
Applicant |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
JANICE E BROWN |
Correspondent |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
JANICE E BROWN |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 04/13/1998 |
Decision Date | 06/29/1998 |
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
|
|
|