# K962054: Orgentec Anti-SS-a (RO) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: American Laboratory Products Co., Ltd.
- Decided: Nov 15, 1996 after 171 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K962054
Methodology: https://510kreport.com/methodology