# K020878: Lyphochek Hemostasis, Models 798, 799

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Apr 15, 2002 after 28 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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 K941737 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K941737: Specialty Assayed Control-1, Helena Laboratories (1994) Summary page 1.
- K941872: Specialty Assayed Control-2 Cat. NO. 5302, Helena Laboratories (1994) Summary page 1.

## Most influential descendants
- K043451: Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator (2005), 0 descendants of its own
- K040275: Lyphochek Hemostasis Control (2004), 0 descendants of its own

## Indications for use
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K020878
Methodology: https://510kreport.com/methodology