Device Classification Name |
counter, differential cell
|
510(k) Number |
K914014 |
Device Name |
FACSTRAK FLOW CYTOMETER |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
J ARNSBERGER |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
J ARNSBERGER |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 09/09/1991 |
Decision Date | 12/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|