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FDA 510(k)

DxH 520 Hematology Instrument

K-Number: K181475 · 2019-03-01

ApplicantBeckman Coulter
Decision Date2019-03-01
Product CodeGKZ
Advisory CommitteeHE
DecisionUnknown

Device Summary

DxH 520 Hematology Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K181475. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DxH 520 Hematology Instrument?

DxH 520 Hematology Instrument is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Beckman Coulter. The 510(k) number is K181475.

When did DxH 520 Hematology Instrument receive FDA 510(k) clearance?

DxH 520 Hematology Instrument received FDA 510(k) clearance on 2019-03-01, under 510(k) number K181475.

Who is the listed applicant for DxH 520 Hematology Instrument?

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

What is the FDA product code for DxH 520 Hematology Instrument?

The FDA product code for DxH 520 Hematology Instrument is GKZ.

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

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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