# K032342: Coulter LH 750 Hematology Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 26, 2003 after 59 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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)

## Most influential descendants
- K041882: Flowcare System (2004), 1 descendant of its own
- K072869: Pointcare Now System (2008), 0 descendants of its own

## 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 COULTERB LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories, The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.

Source page: https://510kreport.com/device/K032342
Methodology: https://510kreport.com/methodology