Skip to content

Modification to Coulter LH 750 Hematology Analyzer

by Beckman Coulter, Inc.

510(k) K052905

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052905 Date18 Nov 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3113-2017 FDA Class II initiated 26 Jun 2017

    Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Modification to Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. It provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

This device modification involves labeling update for quality control (QC) procedure regarding nucleated red blood cells (NRBCs). The device is authorized under FDA 510(k) K052905 and is classified as a Class II device with product code GKZ. It is manufactured by Beckman Coulter, Inc. and is intended for use in clinical laboratory settings.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Modification to Coulter LH 750 Hematology Analyzer used for?

    This device is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. It provides automated reticulocyte analysis, enumeration of nucleated red blood cells (NRBCs), and an automated method for enumeration of RBCs and WBCs in body fluids.

  • What does the modification to the Coulter LH 750 involve?

    The modification involves a labeling update for quality control (QC) procedure regarding nucleated red blood cells (NRBCs). This update ensures proper guidance for laboratory personnel when using the device for NRBC analysis.

  • What is the regulatory status of this device?

    The device is authorized under FDA 510(k) K052905 and is classified as a Class II device with product code GKZ. It is manufactured by Beckman Coulter, Inc. and is intended for use in clinical laboratory settings.

  • What are the key features of the Coulter LH 750 Hematology Analyzer?

    The analyzer provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of red blood cells and white blood cells in body fluids, making it a comprehensive tool for hematology analysis in clinical laboratories.