Device Classification Name |
counter, differential cell
|
510(k) Number |
K000611 |
Device Name |
STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER |
Applicant |
BD Biosciences |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Applicant Contact |
JO-ANN E FABILA |
Correspondent |
BD Biosciences |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Correspondent Contact |
JO-ANN E FABILA |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 02/23/2000 |
Decision Date | 05/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|