# K961941: Liquichek Immunoassay Plus Control Catalog NO. 360,361,362,363

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 16, 1996 after 119 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 K954322 (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)
- K954322: Tri-Point Liquimmune Liquid Assayed Immunoassay Control, Medical Analysis Systems, Inc. (1995) Summary page 1.

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

Source page: https://510kreport.com/device/K961941
Methodology: https://510kreport.com/methodology