JOY · Class II · 21 CFR 864.5260

FDA Product Code JOY: Device, Automated Cell-locating

Leading manufacturers include Sysmex America, Inc..

1
Total
1
Cleared
90d
Avg days
2018
Since

List of Device, Automated Cell-locating devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062
Sysmex America, Inc.
Hematology · 90d

How to use this database

This page lists all FDA 510(k) submissions for Device, Automated Cell-locating devices (product code JOY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →