# K964963: Lyphochek Coagulation Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 20, 1997 after 71 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: 1 generation back to K820450 (1982). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820450: Thromboscreen, Pacific Hemostasis (1982) Summary page 1.

## Most influential descendants
- K990858: Lypochek Coagulation Control, Model Nos. 787, 788, 789 (1999), 2 descendants of its own
- K012722: Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783 (2001), 1 descendant of its own
- K032611: Lyphochek Coagulation Control, Level 4, Model 743 (2003), 0 descendants of its own

## 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/K964963
Methodology: https://510kreport.com/methodology