# K862186: Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 1, 1986 after 22 days
- Product code: JPK (Mixture, Hematology Quality Control)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052838: Liquichek Diabetes Control, Level 1,2,3,4 (2005), 1 descendant of its own
- K123798: Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak (2013), 0 descendants of its own
- K070546: Lyphochek Diabetes Control (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K862186
Methodology: https://510kreport.com/methodology