# K894651: Coulter Positive Control Cells

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Sep 13, 1989 after 51 days
- Product code: GGL (Control, White-Cell)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984216: Immuno-Trol Control Cells (1999), 2 descendants of its own
- K013842: Immuno-Trol Low Cells (2001), 1 descendant of its own
- K141932: Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K894651
Methodology: https://510kreport.com/methodology