# K913305: Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Nov 22, 1991 after 120 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955715: Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) (1996), 3 descendants of its own
- K972354: Abbott Cell-Dyn 3200 System (1997), 2 descendants of its own
- K955673: Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification) (1996), 2 descendants of its own
- 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.

Source page: https://510kreport.com/device/K913305
Methodology: https://510kreport.com/methodology