# K100489: DXH 300 Coulter Cellular Analysis System, DXH 300C Coulter Cellular Analyssi System Model: 71772, 71771

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Cellular
- Decided: Oct 26, 2010 after 249 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The DxH 300 COULTER Cellular Analysis System and the DxHi 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in vitro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, ROB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), OR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.

Source page: https://510kreport.com/device/K100489
Methodology: https://510kreport.com/methodology