# K870233: Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diagnostics
- Decided: Mar 17, 1987 after 55 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030513: Cell-Dyn 1800 System (2003), 2 descendants of its own
- K111534: Abacus 3CP (2012), 0 descendants of its own
- K081495: Cell-Dyn Emerald System (2009), 0 descendants of its own
- K991142: Cell-Dyn 1200 System (1999), 0 descendants of its own

## Recalls of this device
- Nov 30, 2009 · Not classified · Z-1698-2011: The use of the device assemblies has been extended to a 6 month useful life.
- Jun 8, 2009 · Not classified · Z-1629-2010: Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
- Jun 8, 2009 · Not classified · Z-1628-2010: Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
- May 16, 2007 · Not classified · Z-1170-2007: Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)
- May 16, 2007 · Not classified · Z-1171-2007: Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)

Source page: https://510kreport.com/device/K870233
Methodology: https://510kreport.com/methodology