# K951206: Varelisa Parietal Cell Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Elias U.S.A., Inc.
- Decided: Apr 17, 1995 after 31 days
- Product code: MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5110
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K951206
Methodology: https://510kreport.com/methodology