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FDA 510(k)

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

K-Number: K162414 · 2016-11-29

ApplicantBeckman Coulter, Inc.
Decision Date2016-11-29
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-11-29 under approval number K162414. 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 SlideMaker Stainer Coulter Cellular Analysis System?

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K162414.

When was UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System approved by the FDA?

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System received FDA 510(k) clearance on 2016-11-29, under approval number K162414.

What company makes UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System?

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System is manufactured by Beckman Coulter, Inc..

What is the FDA product code for UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System?

The FDA product code for UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System is GKZ.

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Official Source

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

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