The following data is part of a De Novo classification by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Innovance Vwf Ac.
| DeNovo ID | DEN200067 |
| Device Name: | INNOVANCE VWF Ac |
| Classification | Von Willebrand Factor Assay |
| Applicant | Siemens Healthcare Diagnostics Products GmbH emil-von-behring Strasse 76 Marburg, DE 35041 |
| Contact | Petra Dissmann |
| Product Code | QTY |
| CFR Regulation Number | 864.7293 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Hematology |
| Classification Advisory | Hematology |
| Type | Direct |
| Date Received | 2020-10-28 |
| Decision Date | 2022-09-29 |
| Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768028014 | DEN200067 | 000 |
| 00630414639468 | DEN200067 | 000 |