FDA Product Code GKP: Instrument, Coagulation, Automated
Leading manufacturers include Instrumentation Laboratory CO and Instrumentation Laboratory (IL) Co..
FDA 510(k) Cleared Instrument, Coagulation, Automated Devices (Product Code GKP)
About Product Code GKP - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code GKP since 1982, with 49 receiving FDA clearance (average review time: 108 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under GKP have taken an average of 28 days to reach a decision - down from 109 days historically, suggesting improved FDA processing for this classification.
GKP devices are reviewed by the Hematology panel. Browse all Hematology devices →