# K941516: Ventanna Anti-Desmin Primary Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Feb 10, 1997 after 1,049 days
- Product code: DEH (Lambda, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- 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
Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.

Source page: https://510kreport.com/device/K941516
Methodology: https://510kreport.com/methodology