510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTYClass II

Von Willebrand Factor Assay

21 CFR 864.7293 / Hematology
FDA source (opens on fda.gov)

QTY is the FDA product code for Von Willebrand Factor Assay, a class II device type, regulated under 21 CFR 864.7293. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTY
Device name
Von Willebrand Factor Assay
FDA definition
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.
Regulation
21 CFR 864.7293
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QTY

By decision year
1 clearance under product code QTY with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTY by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTY
Applicants holding the most 510(k) clearances under product code QTY
ApplicantClearances
Siemens Healthcare Diagnostics Products Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code