Unicel DxH 800 Coulter Cellular Analysis System
K-Number: K193124 · 2020-04-16
ApplicantBeckman Coulter
Decision Date2020-04-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Unicel DxH 800 Coulter Cellular Analysis System is a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2020-04-16 under approval number K193124. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Unicel DxH 800 Coulter Cellular Analysis System?
Unicel DxH 800 Coulter Cellular Analysis System is a medical device that received FDA 510(k) clearance on 2020-04-16. It is manufactured by Beckman Coulter. The 510(k) number is K193124.
When was Unicel DxH 800 Coulter Cellular Analysis System approved by the FDA?
Unicel DxH 800 Coulter Cellular Analysis System received FDA 510(k) clearance on 2020-04-16, under approval number K193124.
What company makes Unicel DxH 800 Coulter Cellular Analysis System?
Unicel DxH 800 Coulter Cellular Analysis System is manufactured by Beckman Coulter.
What is the FDA product code for Unicel DxH 800 Coulter Cellular Analysis System?
The FDA product code for Unicel DxH 800 Coulter Cellular Analysis System is GKZ.
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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.