# K000398: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Apr 17, 2000 after 70 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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
- K040843: Hemosil Von Willebrand Activity (2004), 0 descendants of its own
- K032139: Reaads Von Willebrand Factor Activity Test Kit, Model 10826 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K000398
Methodology: https://510kreport.com/methodology