# K001256: Control Plasma N

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 24, 2000 after 35 days
- Product code: GIZ (Plasma, Control, Normal)
- 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023309: Control Plasma N (2002), 2 descendants of its own
- K013708: Reference Check, Catalog Number-RCN-10 (2001), 1 descendant of its own
- K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma (2009), 0 descendants of its own
- K043451: Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator (2005), 0 descendants of its own
- K042333: Control Plasma N, Proc Control Plasma (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K001256
Methodology: https://510kreport.com/methodology