FDA Product Code PJE: Blood/plasma Collection Device For Dna Testing
A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing.
Leading manufacturers include Preanalytix GmbH.
8
Total
8
Cleared
144d
Avg days
1998
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Blood/plasma Collection Device For Dna Testing Devices (Product Code PJE)
8 devices
About Product Code PJE - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PJE since 1998, with 8 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PJE devices are reviewed by the Chemistry panel. Browse all Chemistry devices →