FDA Product Code JOY: Device, Automated Cell-locating
Leading manufacturers include Sysmex America, Inc. and Scopio Labs , Ltd..
FDA 510(k) Cleared Device, Automated Cell-locating Devices (Product Code JOY)
About Product Code JOY - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code JOY since 1977, with 35 receiving FDA clearance (average review time: 158 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 JOY have taken an average of 270 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.
JOY devices are reviewed by the Hematology panel. Browse all Hematology devices →