Device Classification Name |
monocyte distribution width quantitative measurement for sepsis risk assessment
|
510(k) Number |
K181599 |
Device Name |
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application |
Applicant |
Beckman Coulter |
11800 SW 147th Ave |
Miami,
FL
33196 -2500
|
|
Applicant Contact |
Radha Goolabsingh |
Correspondent |
Beckman Coulter |
11800 SW 147th Ave |
Miami,
FL
33196 -2500
|
|
Correspondent Contact |
Radha Goolabsingh |
Regulation Number | 866.3215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/18/2018 |
Decision Date | 03/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03145428
|
Reviewed by Third Party |
No
|
Combination Product |
No
|