# K980635: Dako Mouse Anti-Human B-Cell, CD19/Rpe-CY5, Clone HD37

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jul 22, 1998 after 153 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) DAKO Mouse anti-human B-cell, CD19/RPE, clone HD37: named in the summary without a submission number

## Indications for use
Monoclonal Mouse Anti-Human B-cell, CD19, Clone HD37, RPE-Cy5 conjugated, has been developed for use in flow cytometry for the analysis of B-cells. This reagent allows simultaneous detection and quantification of CD19-positive cells (B-cells) in 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. Immunophenotyping of lymphocytes is widely applied for detection and classification of hematopoietic malignancies, and for diagnosis of immunodeficiencies. DAKO Anti-CD19/Cy5 is one of the reagents utilized when performing immunophenotyping of lymphocytes.

Source page: https://510kreport.com/device/K980635
Methodology: https://510kreport.com/methodology