# K941397: Anti-Vimentin Primary Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Feb 10, 1997 after 1,056 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 Medical Systems, Inc. developed the Ventana Anti-Vimentin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Vimentin (clone VIM 3B4) 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/K941397
Methodology: https://510kreport.com/methodology