# K050057: Coulter LH 750 Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 10, 2005 after 30 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 K030606 (2003). 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)
- K030606: Coulter LH 750 Body Fluids Application, Beckman Coulter, Inc. (2003) Summary page 1.

## 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 LH 700 Series Body Fluid Application is a procedure for obtaining in vitro quantitative determinations of leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid, using a COULTER LH 700 Series Hematology Analyzer.

Source page: https://510kreport.com/device/K050057
Methodology: https://510kreport.com/methodology