# K052905: Modification to Coulter LH 750 Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 18, 2005 after 35 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011342 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011342: Coulter LH 750 Hematology Analyzer, Model 6605632, Beckman Coulter, Inc. (2001) Summary page 2.

## Recalls of this device
- Jun 26, 2017 · Class II · 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

## Indications for use
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For InVitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer 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.

Source page: https://510kreport.com/device/K052905
Methodology: https://510kreport.com/methodology