FDA Product Code SAC: Adamts13 Activity Test System
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.
Leading manufacturers include Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM.
FDA 510(k) Cleared Adamts13 Activity Test System Devices (Product Code SAC)
About Product Code SAC - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SAC since 2024, with 0 receiving FDA clearance (average review time: 328 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
SAC devices are reviewed by the Hematology panel. Browse all Hematology devices →