# K955715: Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 8, 1996 after 313 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 K823355 (1982). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K823355: Coulter-Counter #S Plus IV & Lyse S +D, Coulter Electronics, Inc. (1982) Summary page 1.
- K913305: Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer, Unipath, Ltd. (1991) Summary page 2.
- (no number) Coulter® ZBI: named in the summary without a submission number
- (no number) Coulter Hemoglobinometer: named in the summary without a submission number
- (no number) Coulter Model S: named in the summary without a submission number

## Most influential descendants
- K972354: Abbott Cell-Dyn 3200 System (1997), 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.

## Indications for use
The Cell-Dyn 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K955715
Methodology: https://510kreport.com/methodology