# K890491: Cell-Dyn 3000 Multi-Parameter Hematology Analyer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diagnostics
- Decided: Apr 18, 1989 after 77 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955673: Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification) (1996), 2 descendants of its own
- K991539: Excell 22 (1999), 1 descendant of its own
- K980614: Abbott Cell-Dyn 3000 Series Hematology Systems (1998), 1 descendant of its own
- K072869: Pointcare Now System (2008), 0 descendants 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.

Source page: https://510kreport.com/device/K890491
Methodology: https://510kreport.com/methodology