# K973393: Chemmate Lca

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Sep 25, 1997 after 86 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
For the LCA primary antibody reagent: To qualitatively aid in the identification by light microscopy of human cells of lymphoid origin, by recognizing Leukocyte Common Antigen (LCA) in normal and pathologic paraffin embedded tissues processed in neutral buffered formalin, B5, or Bouin's fixative. For the Ancillary Reagents: To aid in the performance of immunohistochemical tests

Source page: https://510kreport.com/device/K973393
Methodology: https://510kreport.com/methodology