# K955673: Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 20, 1996 after 196 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 K890491 (1989). 2 ancestors in all.
2 later devices descend 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)
- K890491: Cell-Dyn 3000 Multi-Parameter Hematology Analyer, Abbott Diagnostics (1989) Summary page 1.
- K913305: Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer, Unipath, Ltd. (1991) Summary page 2.

## Most influential descendants
- K980614: Abbott Cell-Dyn 3000 Series Hematology Systems (1998), 1 descendant of its own
- K061667: Cell-Dyn Ruby System (2006), 0 descendants of its own

## Recalls of this device
- May 11, 2007 · Not classified · Z-1198-2007: The product failed electrostatic discharge testing, which could result in product failure.

## Indications for use
The Cell-Dyn 3000 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K955673
Methodology: https://510kreport.com/methodology