meddevicedb.com FDA Device Reference

INNOVANCE VWF Ac

DEN200067 Class II Direct
Decision Date
2022-09-29
Sponsor / Applicant
Siemens Healthcare Diagnostics Products GmbH

Technical Specification

510(k) Submission ID DEN200067
Product Code QTY
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7293
Decision Date 2022-09-29
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

INNOVANCE VWF Ac received FDA 510(k) clearance under submission number DEN200067, sponsored by Siemens Healthcare Diagnostics Products GmbH. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2022-09-29.

Classification & Regulation

This clearance is catalogued under FDA product code QTY and 21 CFR 864.7293, within the Hematology review panel as a Class II device.