# K012722: Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 18, 2001 after 34 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: 3 generations back to K820450 (1982). 3 ancestors in all.
1 later device descends 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)
- K990858: Lypochek Coagulation Control, Model Nos. 787, 788, 789, Bio-Rad (1999) Summary page 1.

## Most influential descendants
- 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. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin Ill (AT lil) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).

Source page: https://510kreport.com/device/K012722
Methodology: https://510kreport.com/methodology