Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application— 510(k) K181599

Name: FDA 510(k) clearance K181599
Creator: U.S. Food and Drug Administration
Published: 2019-03-18

Substantially Equivalent

Beckman Coulter

FDA 510(k) clearance K181599 for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application, Substantially Equivalent on 2019-03-18. Applicant: Beckman Coulter. Device class: 2.

Clearance details

Applicant: Beckman Coulter
Product code: Code QFS
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2018-06-18
Decision date: 2019-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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