# K960887: Mouse Anti-Human CD4, T-Cell, Helper/Inducer/Fitc & CD8, T-Cell, Suppressor/Cytotoxic/Rpe

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: May 17, 1996 after 74 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CytoStat/Coulter Clone T8-RD1 T4-FITC: named in the summary without a submission number

## Indications for use
Subpopulations of lymphocyte; 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. Mouse Anti-Human T-cell, CD4/FITC, MT310 + Mouse Anti-Human T-cell, CD8/RPE, DK25 (DAKO CD4/CD8) has been developed for use in flow cytometry for the analysis of T-helper/inducer cells and T-cytotoxic/suppressor cells. This reagent allows simultaneous detection and quantification of helper/inducer T-cells (CD4 + cells) and cytotoxic/suppressor T-cells (CD8 + cells) in peripheral blood of normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.

Source page: https://510kreport.com/device/K960887
Methodology: https://510kreport.com/methodology