# K972388: Vista Antigen Salmonella O Group C

- Pathway: 510(k) (Traditional)
- Applicant: Lee Laboratories, Inc.
- Decided: Aug 25, 1997 after 60 days
- Product code: GNC (Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3550
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

Source page: https://510kreport.com/device/K972388
Methodology: https://510kreport.com/methodology