# K984475: Liquichek Anti-SCL-70 Control, Eia, Model 212

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 22, 1998 after 6 days
- Product code: LKJ (Antinuclear Antibody, Antigen, Control)
- 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
Longest line of descent: 1 generation back to K954723 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954723: Enzyme Immunoassay Ana Screening Test Kit, Helix Diagnostics, Inc. (1995) Summary page 1.

## Most influential descendants
- K024226: Liquichek Anti-SCL-70 Control, Positive, Catalog #116 (2003), 0 descendants of its own

## Indications for use
Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-Scl-70 autoantibodies.

Source page: https://510kreport.com/device/K984475
Methodology: https://510kreport.com/methodology