Device Classification Name |
Lymphocyte Separation Medium
|
510(k) Number |
K854093 |
Device Name |
LEUCO PREP |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MACK CENTRE DR. |
P.O.BOX 2224 |
PARAMUS,
NJ
07652
|
|
Applicant Contact |
RUSSELL ARNSBERGER |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MACK CENTRE DR. |
P.O.BOX 2224 |
PARAMUS,
NJ
07652
|
|
Correspondent Contact |
RUSSELL ARNSBERGER |
Regulation Number | 864.8500
|
Classification Product Code |
|
Date Received | 10/07/1985 |
Decision Date | 11/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|