# K960987: Liquichek Rheumatoid Factor Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 4, 1996 after 85 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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 K923578 (1992). 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)
- K923578: Liquichek Rheumatoid Factor Control, Bio-Rad (1992) Summary page 1.

## Indications for use
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies.

Source page: https://510kreport.com/device/K960987
Methodology: https://510kreport.com/methodology