# K973389: Chemmate UCHL1 (CD45RO) Prediluted Antibody for Immunohistochemical Staining

- 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 qualitatively aid in the identification by light microscopy of human cells of T-cell lineage, by recognizing CD45R0 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 as T-cell in origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple immunochemical stains.

Source page: https://510kreport.com/device/K973389
Methodology: https://510kreport.com/methodology