# K032611: Lyphochek Coagulation Control, Level 4, Model 743

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad
- Decided: Sep 17, 2003 after 23 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K820450 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012722: Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783, Bio-Rad (2001) Summary page 2.

## Indications for use
Lyphochek@Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Source page: https://510kreport.com/device/K032611
Methodology: https://510kreport.com/methodology