SAC — Adamts13 Activity Test System Class II
FDA product code SAC covers "Adamts13 Activity Test System", a Class II medical device regulated under 21 CFR 864.7297. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SAC
- Device Class
- Class II
- Regulation Number
- 864.7297
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230024 | technoclone herstellung von diagnostika und arzneimitteln gm | Technozym ADAMTS13 Activity | February 28, 2024 |