FDA 510(k) Application Details - DEN230024

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230024
Device Name	Technozym ADAMTS13 Activity
Applicant	Technoclone Herstellung von Diagnostika und Arzneimitteln Gm Brunner Strasse 67 Vienna 1230 AT Other 510(k) Applications for this Company
Contact	Nikolaus Binder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2023
Decision Date	02/28/2024
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review