# K043584: Liquichek BNP Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 8, 2005 after 42 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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: 5 generations back to K961828 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040277: Liquichek Cardiac Marker Control LT, Bio-Rad Laboratories, Inc. (2004) Summary page 1.

## Indications for use
Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).

Source page: https://510kreport.com/device/K043584
Methodology: https://510kreport.com/methodology