# K943518: Sta System Control [N] + [P] Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Mar 21, 1995 after 243 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K120014: Sta- Coag Control (N+Abn) Plus (2013), 0 descendants of its own

## Recalls of this device
- Nov 18, 2019 · Class II · Z-0738-2020: A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This 
- Aug 23, 2011 · Not classified · Z-1044-2012: Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

Source page: https://510kreport.com/device/K943518
Methodology: https://510kreport.com/methodology