# K042724: Modification to Coulter LH 500 Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 29, 2004 after 28 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: 2 generations 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)
- K032000: Coulter LH 500 Hematology Analyzer, Beckman Coulter, Inc. (2003) Summary page 1.

## Indications for use
The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi-automated reticulocyte analysis.

Source page: https://510kreport.com/device/K042724
Methodology: https://510kreport.com/methodology