# K052838: Liquichek Diabetes Control, Level 1,2,3,4

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 9, 2005 after 33 days
- Product code: GGM (Control, Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K862186 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862186: Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II, Bio-Rad (1986) Summary page 1.

## Most influential descendants
- K123798: Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K052838
Methodology: https://510kreport.com/methodology