DEN230024
- 510(k) number
- DEN230024
- Device name
- Technozym ADAMTS13 Activity
- Applicant
- Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM AT
- Product code
- SAC — Adamts13 Activity Test System
- Decision date
- 2024-02-28
- Date received
- 2023-04-06
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Hematology
Official FDA record: DEN230024
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.