# K941872: Specialty Assayed Control-2 Cat. NO. 5302

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Nov 21, 1994 after 217 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020878: Lyphochek Hemostasis, Models 798, 799 (2002), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K941872
Methodology: https://510kreport.com/methodology