510(k) K181599

Device

Unicel DxH 800 Cellular Analysis System With Early Sepsis Indicator Application

Applicant

Beckman Coulter

510(k) number

K181599

Product code

QFS  

Decision

Substantially Equivalent (SESE)

Decision date

2019-03-18

Date received

2018-06-18

Regulation

866.3215

Classification name

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No