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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K162414.

When did UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System receive FDA 510(k) clearance?

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

Who is the listed applicant for UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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