# K973390: Chemmate L26 (CD20)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Oct 3, 1997 after 85 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- 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 no predicate by number.

## Indications for use
To qualitative aid in the identification by light microscopy of human cells of B-cell lineage, by recognizing CD20- antigen in normal and pathologic paraffin embedded tissues processed in neutral buffered formalin, B5, or Bouin's fixative. Positive results aid in the classification of lymphomas of B-cell origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphologic criteria and multiple chemical and immunohistochemical stains.

Source page: https://510kreport.com/device/K973390
Methodology: https://510kreport.com/methodology