Device Classification Name |
Counter, Differential Cell
|
510(k) Number |
K946055 |
Device Name |
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP |
Applicant |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Applicant Contact |
ANNA LONGWELL |
Correspondent |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Correspondent Contact |
ANNA LONGWELL |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 11/28/1994 |
Decision Date | 02/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|