# K955909: Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell (Suppressor/Cytotoxic) Rpe

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Mar 28, 1996 after 90 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
Longest line of descent: 1 generation back to K944253 (1994). 1 ancestor in all.
1 later device descends 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)
- K944253: Monoclonal Mouse Anti-Human T-Cell, CD8, Rpe-Conjugated, Clone DK25, Dako Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K942797: Monoclonal Mouse Anti-Human T-Cell, Dako Corp. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060423: Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres (2006), 0 descendants of its own

## Indications for use
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.

Source page: https://510kreport.com/device/K955909
Methodology: https://510kreport.com/methodology