FDA Product Code CFR: Hexokinase, Glucose
Leading manufacturers include Roche Diagnostics and Abbott Ireland.
FDA 510(k) Cleared Hexokinase, Glucose Devices (Product Code CFR)
About Product Code CFR - Regulatory Context
510(k) Submission Activity
145 total 510(k) submissions under product code CFR since 1976, with 145 receiving FDA clearance (average review time: 91 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for CFR submissions have been consistent, averaging 99 days recently vs 91 days historically.
CFR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →