FDA Product Code GJT: Plasma, Coagulation Factor Deficient
Leading manufacturers include Instrumentation Laboratory CO.
79
Total
79
Cleared
116d
Avg days
1988
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Plasma, Coagulation Factor Deficient Devices (Product Code GJT)
79 devices
About Product Code GJT - Regulatory Context
510(k) Submission Activity
79 total 510(k) submissions under product code GJT since 1988, with 79 receiving FDA clearance (average review time: 116 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
GJT devices are reviewed by the Hematology panel. Browse all Hematology devices →