INNOVANCE VWF Ac

Von Willebrand Factor Assay

Siemens Healthcare Diagnostics Products GmbH

The following data is part of a De Novo classification by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Innovance Vwf Ac.

Pre-market Notification Details

DeNovo IDDEN200067
Device Name:INNOVANCE VWF Ac
ClassificationVon Willebrand Factor Assay
Applicant Siemens Healthcare Diagnostics Products GmbH emil-von-behring Strasse 76 Marburg,  DE 35041
ContactPetra Dissmann
Product CodeQTY  
CFR Regulation Number864.7293 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardHematology
Classification AdvisoryHematology
TypeDirect
Date Received2020-10-28
Decision Date2022-09-29
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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768028014 DEN200067 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.