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FDA 510(k)

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

K-Number: K181599 · 2019-03-18

ApplicantBeckman Coulter
Decision Date2019-03-18
Product CodeQFS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2019-03-18 under approval number K181599. The device is classified under product code QFS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is a medical device that received FDA 510(k) clearance on 2019-03-18. It is manufactured by Beckman Coulter. The 510(k) number is K181599.

When was Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application approved by the FDA?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application received FDA 510(k) clearance on 2019-03-18, under approval number K181599.

What company makes Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is manufactured by Beckman Coulter.

What is the FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

The FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is QFS.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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