Device Classification Name |
Counter, Differential Cell
|
510(k) Number |
K051215 |
Device Name |
CELL-DYN SAPPHIRE SYSTEM |
Applicant |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
MICHELLE ROEDING |
Correspondent |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
MICHELLE ROEDING |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 05/12/2005 |
Decision Date | 07/21/2005 |
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
|
|
|