# K032013: Coulter Act 5DIFF AL Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 24, 2003 after 24 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030291: Coulter Act 5DIFF Autoloader (AL), Beckman Coulter, Inc. (2003)
- K022161: Modification to Coulter LH 750 Hematology Analyzer, Model 6605632, Beckman Coulter, Inc. (2002)

## Most influential descendants
- K042173: Coulter a T 5DIFF Cap Pierce (CP) (2004), 0 descendants of its own

## Indications for use
The COULTER ACTM5diff AL Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

Source page: https://510kreport.com/device/K032013
Methodology: https://510kreport.com/methodology