# K944253: Monoclonal Mouse Anti-Human T-Cell, CD8, Rpe-Conjugated, Clone DK25

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Nov 21, 1994 after 82 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K955909: Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell (Suppressor/Cytotoxic) Rpe (1996), 1 descendant of its own
- K060423: Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K944253
Methodology: https://510kreport.com/methodology