# K915891: Toxo Igg Elisa Test (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Gull Laboratories, Inc.
- Decided: Mar 4, 1992 after 71 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963296: Incstar Toxoplasma Igg Alisa Assay (Cat.#7565) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K915891
Methodology: https://510kreport.com/methodology