# K960427: Abbott Cell-Dyn 3500R System

- Pathway: 510(k) (Traditional)
- Applicant: Sequoia Turner Corp.
- Decided: May 2, 1996 after 94 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 K872166 (1987). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872166: Facscan Flow Cytometer - Reticcount Reti. Enu. Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1987) Summary page 1.

## 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-1199-2007: The product failed electrostatic discharge testing, which could result in product failure.

## Indications for use
The Cell-Dyn 3500R System is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K960427
Methodology: https://510kreport.com/methodology