DEN200067 is an FDA 510(k) submission for the INNOVANCE VWF Ac. This device is classified as a Von Willebrand Factor Assay (Class II - Special Controls, product code QTY).
Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Not Cleared (DENG) decision on September 29, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7293. 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..
| 510(k) Number | DEN200067 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 28, 2020 |
| Decision Date | September 29, 2022 |
| Days to Decision | 701 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | QTY — Von Willebrand Factor Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7293 |
| 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. |