QTY · Class II · 21 CFR 864.7293

FDA Product Code QTY: Von Willebrand Factor Assay

A Von Willebrand Factor Assay Is A Prescription Device Intended For The Measurement Of Von Willebrand Factor Activity Or Von Willebrand Factor Size Distribution In Human Plasma.

1
Total
0
Cleared
701d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Von Willebrand Factor Assay Devices (Product Code QTY)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code QTY - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTY since 2022, with 0 receiving FDA clearance (average review time: 701 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.