# K962674: Sta - VWF Control [N]+[P] Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jul 23, 1996 after 14 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The STA®-vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (VWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

Source page: https://510kreport.com/device/K962674
Methodology: https://510kreport.com/methodology