# K984473: Liquichek Ana Control, Eia Screen, Model 205

- 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Liquichek ANA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).

Source page: https://510kreport.com/device/K984473
Methodology: https://510kreport.com/methodology