# K042173: Coulter a T 5DIFF Cap Pierce (CP)

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 12, 2004 after 62 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: 3 generations back to K011342 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922704: Coulter Maxm W/ Autoloader, Coulter Electronics, Inc. (1992) Summary page 1.
- K030291: Coulter Act 5DIFF Autoloader (AL), Beckman Coulter, Inc. (2003) Summary page 1.
- K032013: Coulter Act 5DIFF AL Hematology Analyzer, Beckman Coulter, Inc. (2003) Summary page 1.

## Indications for use
The COULTER® AcT™ 5diff Cap Pierce (CP) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed vial or open vial mode.

Source page: https://510kreport.com/device/K042173
Methodology: https://510kreport.com/methodology