Device Classification Name |
counter, differential cell
|
510(k) Number |
BK010044 |
Tradename |
stemONE System for EPICS XL/ XL-MCL Flow Cytometry Systems
|
Device Name |
Counter, Differential Cell |
Original Applicant |
Beckman Coulter, Inc. |
11800 sw 147 avenue |
(m/c: 31-b06) |
miami,
FL
33196
2500
|
|
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 10/16/2001 |
Decision Date | 05/20/2002 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
Yes
|
|
|