# K992550: Liquichek Immunology Control Level 1, 2, 3

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 11, 1999 after 12 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 K945651 (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)
- K945651: Liquichek (TM Immunology Control, Levels 1.2. and 3, Bio-Rad (1995) Summary page 1.

## Indications for use
Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K992550
Methodology: https://510kreport.com/methodology