Coulter LH 750 Hematology Analyzer
by Beckman Coulter, Inc. 2 variants
510(k) K050057
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050057 | Date10 Feb 2005 | StatusActive |
Recalls
-
- Terminated Z-3113-2017
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
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 19 Sep 2026
The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. It is designed to provide accurate and reliable results for a wide range of hematology tests.
The analyzer features an advanced bar-code reader for easy sample identification and can perform up to 80 tests per hour with a single tube of blood. It includes nucleated red blood cell (NRBC) enumeration and random access capabilities, helping high-volume labs eliminate manual presorting of samples and speed results to clinicians.
Other devices from Beckman Coulter, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of hematology tests can the Coulter LH 750 perform, and how does its throughput compare to manual methods?
The Coulter LH 750 is designed to perform a wide range of quantitative hematology tests, including complete blood counts (CBC) and leukocyte differential counts. It also includes nucleated red blood cell (NRBC) enumeration, which helps identify immature red blood cells. Unlike manual methods, this analyzer can process up to 80 tests per hour using a single blood tube, significantly increasing efficiency in high-volume clinical laboratories.
How does the Coulter LH 750 help streamline workflow in busy labs, and what features support this?
The Coulter LH 750 eliminates the need for manual presorting of samples by offering random access capabilities, allowing labs to process tests in any order. Its advanced bar-code reader simplifies sample identification, reducing errors and speeding up result delivery to clinicians. This automation helps labs handle high volumes more efficiently while maintaining accuracy.
Is the Coulter LH 750 intended for use in any specific clinical settings, or is it suitable for general laboratory use?
The Coulter LH 750 is intended for in vitro diagnostic use in clinical laboratories, making it suitable for general hematology testing. Its design supports high-volume environments, such as large hospitals or reference labs, where rapid and accurate results are critical. The device is not limited to specialized settings but is optimized for routine and high-throughput laboratory workflows.
What regulatory pathway was followed for the Coulter LH 750, and what does this mean for its use in clinical settings?
The Coulter LH 750 underwent a 510(k) premarket notification review with the FDA, specifically classified as Substantially Equivalent (SE) under the Hematology advisory committee (HE). This means the device was determined to be at least as safe and effective as a legally marketed predicate device, allowing it to be marketed for its intended clinical use in laboratories. The Special clearance type indicates it may have unique features or modifications compared to earlier models.