# K912291: Distat Anti-SCL-70 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Jul 30, 1991 after 68 days
- Product code: LKJ (Antinuclear Antibody, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Oct 21, 2016 · Class III · Z-2922-2018: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Source page: https://510kreport.com/device/K912291
Methodology: https://510kreport.com/methodology