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510(k) DEN200067

INNOVANCE VWF Ac by Siemens Healthcare Diagnostics Products GmbH — Product Code QTY

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 29, 2022
Date Received
October 28, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Von Willebrand Factor Assay
Device Class
Class II
Regulation Number
864.7293
Review Panel
HE
Submission Type

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.

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