# K984400: Liquichek Ana Control, Speckled Pattern, Model 202

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 18, 1998 after 9 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, 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 K813592 (1982). 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)
- K813592: Quantafluor Fluorescent Test Reagents, Kallestad Laboratories, Inc. (1982) Summary page 1.

## Indications for use
Liquichek ANA Control, Speckled Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Source page: https://510kreport.com/device/K984400
Methodology: https://510kreport.com/methodology