# K030606: Coulter LH 750 Body Fluids Application

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 21, 2003 after 55 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Manual cell count method in a counting chamber by a skilled competent technician: named in the summary without a submission number

## Most influential descendants
- K061616: Coulter LH 780 Hematology Analyzer (2006), 1 descendant of its own
- K090346: Advia 2120/2120I Body Fluids (2010), 0 descendants of its own
- K081930: Unicel DXH 800 Coulter Cellular Analysis System (2008), 0 descendants of its own
- K061574: Coulter LH 750 Hematology Analyzer, Model 6605632 (2006), 0 descendants of its own
- K050057: Coulter LH 750 Hematology Analyzer (2005), 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 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 also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The system also provides an automated method for enumeration of RBCs and WBCs in body fluids. Future commercialization will add ISOTONB 4 diluent /Lyse S 8 4 Lytic reagent to the indications for use.

Source page: https://510kreport.com/device/K030606
Methodology: https://510kreport.com/methodology