# K133005: Hemosil Von Willebrand Activity Assay

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 13, 2014 after 169 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
IL HemosIL von Willebrand Activity is an in vitro diagnostic automated latex enhanced immunoturbidometric assay for the quantitative determination of von Willebrand activity in human citrated plasma on IL Coagulation Systems.

Source page: https://510kreport.com/device/K133005
Methodology: https://510kreport.com/methodology