INNOVANCE VWF Ac
FDA 510(k) clearance DEN200067 · decided 2022-09-29
Clearance details
- K-number
- DEN200067
- Device name
- INNOVANCE VWF Ac
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- Decision
- Unknown
- Date received
- 2020-10-28
- Decision date
- 2022-09-29
- Days to decision
- 701 days
- Clearance type
- Direct
- Product code
- QTY
- Device class
- 2
- Regulation number
- 864.7293
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.