510(k) DEN230024
DEN230024 is an FDA 510(k) premarket notification submitted by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM for the device "Technozym ADAMTS13 Activity". The FDA issued a decision of De Novo Granted on February 28, 2024. The device falls under product code SAC (Adamts13 Activity Test System), a Class II device regulated under 21 CFR 864.7297.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 28, 2024
- Date Received
- April 6, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adamts13 Activity Test System
- Device Class
- Class II
- Regulation Number
- 864.7297
- Review Panel
- HE
- Submission Type
An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.