Device Classification Name |
counter, differential cell
|
510(k) Number |
K182886 |
Device Name |
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer |
Applicant |
Beckman Coulter |
11800 SW 147th Ave |
Miami,
FL
33196 -2500
|
|
Applicant Contact |
Samy Puccio |
Correspondent |
Beckman Coulter |
11800 SW 147th Ave |
Miami,
FL
33196 -2500
|
|
Correspondent Contact |
Samy Puccio |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 10/15/2018 |
Decision Date | 09/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|