510(k) DEN230024
- Device
- Technozym ADAMTS13 Activity
- Applicant
- Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
- 510(k) number
- DEN230024
- Product code
- SAC
- Decision
- Unknown (DENG)
- Decision date
- 2024-02-28
- Date received
- 2023-04-06
- Regulation
- 864.7297
- Classification name
- Adamts13 Activity Test System
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Nikolaus Binder
- Address
- Brunner Strasse 67 Vienna AT 1230 1230
FDA Registration Numbers
- 3003453957
Source Documents
510(k) summary PDF not indicated by FDA