FDA Product Code PZJ: Lynch Syndrome Test System
The Lynch Syndrome Test System Is Used To Identify Loss Of Dna Mismatch Repair Proteins Or Microsatellite Instability In Tumor Tissue From Cancer Patients For The Purpose Of Identifying Patients Who May Benefit From Additional Testing For The Inherited Cancer Predisposition Lynch Syndrome
Leading manufacturers include Promega Corporation, Biocartis NV and Leica Biosystems Newcastle, Ltd..
FDA 510(k) Cleared Lynch Syndrome Test System Devices (Product Code PZJ)
About Product Code PZJ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PZJ since 2017, with 3 receiving FDA clearance (average review time: 470 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
PZJ devices are reviewed by the Pathology panel. Browse all Pathology devices →