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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 a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2019-03-01 under approval 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. It is manufactured by Beckman Coulter. The 510(k) number is K181475.

When was DxH 520 Hematology Instrument approved by the FDA?

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

What company makes DxH 520 Hematology Instrument?

DxH 520 Hematology Instrument is manufactured by Beckman Coulter.

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)

K160538Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc. K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHORIBA ABX SAS K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics

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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