# K061574: Coulter LH 750 Hematology Analyzer, Model 6605632

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 21, 2006 after 44 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011342 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K030606: Coulter LH 750 Body Fluids Application, Beckman Coulter, Inc. (2003) Summary page 1.

## Indications for use
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro 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/K061574
Methodology: https://510kreport.com/methodology