# K042837: Liquichek Elevated CRP Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 2, 2004 after 19 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: 2 generations back to K002460 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642, Bio-Rad (2001) Summary page 1.

## Indications for use
Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).

Source page: https://510kreport.com/device/K042837
Methodology: https://510kreport.com/methodology