# K952622: Cryo Check Normal Human Reference Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Oct 30, 1995 after 144 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma (2009), 0 descendants of its own
- K022046: Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag Coagulation Control (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K952622
Methodology: https://510kreport.com/methodology