FDA Product Code JFY: Enzymatic Method, Creatinine
Leading manufacturers include Siemens Healthcare Diagnostics, Inc. and Qstag, Inc..
FDA 510(k) Cleared Enzymatic Method, Creatinine Devices (Product Code JFY)
About Product Code JFY - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code JFY since 1981, with 49 receiving FDA clearance (average review time: 134 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 JFY have taken an average of 185 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
JFY devices are reviewed by the Chemistry panel. Browse all Chemistry devices →