# K022991: Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2, and 3-3 ML, Model 594, 595, 596

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 17, 2002 after 8 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K011494 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011494: Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology Control Level 1, 3 ML, Liquichek Immunology Control, Bio-Rad (2001)

## Most influential descendants
- K140764: Liquichek Immunologycontrol-Level 1,Level 2, Level 3, Minipak (2014), 0 descendants of its own
- K131992: Multichem P (2013), 0 descendants of its own
- K130761: Liquichek Immunology Control, Level 1,2,3, Trilevel Minipak (2013), 0 descendants of its own

## Indications for use
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.

Source page: https://510kreport.com/device/K022991
Methodology: https://510kreport.com/methodology