# K984462: Liquichek Ena Control, Eia Screen, Model NO. 206

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 22, 1998 after 6 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And 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 ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.

Source page: https://510kreport.com/device/K984462
Methodology: https://510kreport.com/methodology