510(k) DEN200067
- Device
- INNOVANCE VWF Ac
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- 510(k) number
- DEN200067
- Product code
- QTY
- Decision
- Unknown (DENG)
- Decision date
- 2022-09-29
- Date received
- 2020-10-28
- Regulation
- 864.7293
- Classification name
- Von Willebrand Factor Assay
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Petra Dissmann
- Address
- Emil-Von-Behring Strasse 76 Marburg DE 35041 35041
FDA Registration Numbers#
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA