# K961435: Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/Rpe

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jun 14, 1996 after 60 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 K943284 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945692: Monoclonal Mouse Anti-Human T-Cell, CD2, Clone MT910 Fitc-Conjugated, (Anti-CD2,Fitc, MT910), Dako Corp. (1995) Summary page 1.
- K943284: Monoclonal Mouse Anti-Human B-Cell, Dako Corp. (1994) Summary page 1.

## Indications for use
Mouse Anti-Human T-cell, CD2/FITC, MT910 + Mouse Anti-Human B-cell, CD19/RPE, HD37 (DAKO Anti-CD2/FITC and Anti-CD19/RPE) has been developed for use in flow cytometry for the analysis of CD2" T-cells and CD19" B-cells. This reagent allows simultaneous detection and guantification of T- and B-cells in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monocional antibody (MAD) combinations for routine immunophenotyping of lymphocytes in peripheral bicod using flow cytometry.

Source page: https://510kreport.com/device/K961435
Methodology: https://510kreport.com/methodology