FDA Product Code QSA: Circulating Tumor Cell (ctc) Enrichment Device
A Circulating Tumor Cell Enrichment Device Is An In Vitro Diagnostic Device Used To Enrich Circulating Tumor Cells From The Peripheral Blood Of Patients Diagnosed With Cancer For Subsequent In Vitro Diagnostic Testing.
Leading manufacturers include Angle Europe , Ltd..
FDA 510(k) Cleared Circulating Tumor Cell (ctc) Enrichment Device Devices (Product Code QSA)
About Product Code QSA - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QSA since 2022, with 0 receiving FDA clearance (average review time: 603 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QSA devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →