FDA Product Code LCO: Platelet Factor 4 Radioimmunoassay
Leading manufacturers include Instrumentation Laboratory CO and Instrumentation Laboratory (IL) Co..
FDA 510(k) Cleared Platelet Factor 4 Radioimmunoassay Devices (Product Code LCO)
About Product Code LCO - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code LCO since 1986, with 13 receiving FDA clearance (average review time: 109 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 LCO have taken an average of 90 days to reach a decision - down from 111 days historically, suggesting improved FDA processing for this classification.
LCO devices are reviewed by the Hematology panel. Browse all Hematology devices →