FDA Product Code GFO: Activated Partial Thromboplastin
Leading manufacturers include Instrumentation Laboratory CO and Instrumentation Laboratory (IL) Co..
FDA 510(k) Cleared Activated Partial Thromboplastin Devices (Product Code GFO)
About Product Code GFO - Regulatory Context
510(k) Submission Activity
52 total 510(k) submissions under product code GFO since 1976, with 52 receiving FDA clearance (average review time: 100 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 GFO have taken an average of 30 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.
GFO devices are reviewed by the Hematology panel. Browse all Hematology devices →