FDA Product Code KQJ: System, Fibrinogen Determination
Leading manufacturers include Instrumentation Laboratory (IL) Co..
FDA 510(k) Cleared System, Fibrinogen Determination Devices (Product Code KQJ)
About Product Code KQJ - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code KQJ since 1980, with 28 receiving FDA clearance (average review time: 80 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 KQJ have taken an average of 28 days to reach a decision - down from 82 days historically, suggesting improved FDA processing for this classification.
KQJ devices are reviewed by the Hematology panel. Browse all Hematology devices →