FDA Product Code GGW: Test, Time, Partial Thromboplastin
Leading manufacturers include Instrumentation Laboratory (IL) Co..
FDA 510(k) Cleared Test, Time, Partial Thromboplastin Devices (Product Code GGW)
About Product Code GGW - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code GGW since 1979, with 32 receiving FDA clearance (average review time: 117 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GGW have taken an average of 30 days to reach a decision - down from 119 days historically, suggesting improved FDA processing for this classification.
GGW devices are reviewed by the Hematology panel. Browse all Hematology devices →