Device Classification Name |
counter, differential cell
|
510(k) Number |
K980858 |
Device Name |
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION |
Applicant |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Applicant Contact |
CINDY MORROW |
Correspondent |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
2350 QUME DR. |
SAN JOSE,
CA
95131 -1807
|
|
Correspondent Contact |
CINDY MORROW |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 03/05/1998 |
Decision Date | 05/22/1998 |
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
|
|
|